138102

GUDID 20653405003356

CONMED ACCESSORY ELECTRODE, NEEDLE ELECTRODE

Conmed Corporation

Open-surgery electrosurgical electrode, monopolar, single-use

• Primary Device ID: 20653405003356
• NIH Device Record Key: a8a4d388-0dc5-44d6-b6fc-03ef62d9cb3f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 138102
• Catalog Number: 138102
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 40
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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(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

• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -34 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653405003352 [Unit of Use]
GS1	10653405003359 [Package]; Contains: 30653405003353; Package: Box [40 Units]; In Commercial Distribution
GS1	20653405003356 [Package]; Contains: 30653405003353; Package: BOX [40 Units]; In Commercial Distribution
GS1	30653405003353 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K943542

FDA Product Code

• GEI: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-24

Devices Manufactured by Conmed Corporation

• 30845854053137 - MEGADYNE: 2024-08-21 Filter Fluid Trap
• 30653405990196 - PlumeSafe® X5™: 2024-08-21 Filter, 7/8” (22 mm), 3/8” (9.5 mm), 7/8” (22 mm) Ports
• 10653405987550 - PlumeSafe® X5™: 2024-08-20 Smoke Evacuation Unit with PlumeSafe X5 Smoke Evacuation Filter
• 10653405987994 - PlumeSafe® X5™: 2024-08-20 Filter, 7/8” (22 mm), 3/8” (9.5 mm), 7/8” (22 mm) Ports
• 10653405988007 - PlumeSafe® X5™: 2024-08-20 Filter, 1” (25 mm), 3/8” (9.5 mm), 1” (25 mm) Ports
• 30653405987561 - PlumeSafe® X5™: 2024-08-20 Smoke Evacuation Unit
• 30653405988018 - PlumeSafe® X5™: 2024-08-20 Filter, 1” (25 mm), 3/8” (9.5 mm), 1” (25 mm) Ports
• 30845854045224 - CONMED: 2024-08-16 GAS WARMER