60-5160-004

GUDID 20653405034787

Laparoscopic Electrode with 4mm Pin and Disposable Cord

Conmed Corporation

Open-surgery electrosurgical electrode, monopolar, single-use

• Primary Device ID: 20653405034787
• NIH Device Record Key: 66be2b01-b37d-4dc9-9486-c7a1d8235a9d
• Commercial Distribution Discontinuation: 2016-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 60-5160-004
• Catalog Number: 60-5160-004
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 5
• 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

Device Dimensions

• Length: 32 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 32 Centimeter
• Outer Diameter: 5 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653405034783 [Unit of Use]
GS1	20653405034787 [Package]; Contains: 30653405034784; Package: BOX [5 Units]; Discontinued: 2016-12-31; Not in Commercial Distribution
GS1	30653405034784 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K904240

FDA Product Code

• HFG: COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)

Sterilization

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

[20653405034787]

Ethylene Oxide

[20653405034787]

Ethylene Oxide

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

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• 00810021867380 - CoLink®: 2025-07-11 CoLink® Afx, Locking Screw, 2.7X16.0MM, 2-Pack
• 00810021867403 - CoLink®: 2025-07-11 CoLink® Afx, Locking Screw, 3.5X12.0MM, 2-Pack
• 00810021867410 - CoLink®: 2025-07-11 CoLink® Afx, Locking Screw, 3.5X14.0MM, 2-Pack
• 00810021867427 - CoLink®: 2025-07-11 CoLink® Afx, LOW-PRO CORTICAL SCREW, 3.5X12.0MM, 2-Pack
• 00810021867434 - CoLink®: 2025-07-11 CoLink® Afx, LOW-PRO CORTICAL SCREW, 3.5X14.0MM, 2-Pack
• 08101755018714 - CoLink®: 2025-07-11 CoLink® Afx, Locking Screw, 3.5X10.0MM, 2-Pack
• 08101755018721 - CoLink®: 2025-07-11 CoLink® Afx, Locking Screw, 3.5X16.0MM, 2-Pack