HELIXAR 60-8480-001

GUDID 30653405001977

HELIXAR WIRELESS FOOTSWITCH KIT

Conmed Corporation

Argon-enhanced electrosurgical system Argon-enhanced electrosurgical system Argon-enhanced electrosurgical system Argon-enhanced electrosurgical system Argon-enhanced electrosurgical system Argon-enhanced electrosurgical system Argon-enhanced electrosurgical system Argon-enhanced electrosurgical system Argon-enhanced electrosurgical system Argon-enhanced electrosurgical system Argon-enhanced electrosurgical system Argon-enhanced electrosurgical system Argon-enhanced electrosurgical system Argon-enhanced electrosurgical system Argon-enhanced electrosurgical system Argon-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Inert gas-enhanced electrosurgical system Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical Foot-switch, electrical

• Primary Device ID: 30653405001977
• NIH Device Record Key: 82ff0dd2-ab0c-431f-bd92-600c54e5a193
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HELIXAR
• Version Model Number: 60-8480-001
• Catalog Number: 60-8480-001
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 100 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 38 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 and 20 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -29 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 0 and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	30653405001977 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172671

FDA Product Code

• GEI: Electrosurgical, cutting & coagulation & accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-12

On-Brand Devices [HELIXAR]

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• 20653405005534: HELIXAR ESU
• 30653405001977: HELIXAR WIRELESS FOOTSWITCH KIT
• 30653405001960: HELIXAR CART
• 20653405001994: HELIXAR STACKING ADAPTER FOR SYSTEM 5000 ELECTROSURGICAL UNIT STACKING ADAPTER
• 20653405001987: SMOKE KIT, HELIXAR AER DEFENSE DOOR ASSEMBLY
• 20653405001963: HELIXAR CART
• 30653405000758: HELIXAR:GENERATOR, CART, MONO F/S, BI F/S
• 10653405001966: HELIXAR CART
• 10653405005537: HELIXAR 100 - 240 VAC 50/60 HZ ELECTROSURGICAL UNIT WITH ARGON BEAM COAGULATOR