HELIXAR 60-8480-001

GUDID 20653405001970

HELIXAR WIRELESS FOOTSWITCH KIT

Conmed Corporation

Argon-enhanced electrosurgical system

• Primary Device ID: 20653405001970
• NIH Device Record Key: 6a3730ab-ff1c-4baf-a730-df99a71b6424
• Commercial Distribution Discontinuation: 2018-03-09
• Commercial Distribution Status: Not 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: false
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653405001976 [Primary]
GS1	20653405001970 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152860

FDA Product Code

• GEI: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [HELIXAR]

• 20653405001970: HELIXAR WIRELESS FOOTSWITCH KIT
• 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