60-0867-001

GUDID 40653405008607

3/8" LOOP ELECTROSURGICAL ELECTRODE

Conmed Corporation

Open-surgery electrosurgical electrode, monopolar, single-use

• Primary Device ID: 40653405008607
• NIH Device Record Key: ac1f37d5-c55c-4818-a77b-3a98bb633db7
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 60-0867-001
• Catalog Number: 60-0867-001
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 6
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653405008609 [Unit of Use]
GS1	20653405008603 [Package]; Contains: 30653405008600; Package: BAG [6 Units]; In Commercial Distribution
GS1	30653405008600 [Primary]
GS1	40653405008607 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K800597

FDA Product Code

• GEI: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

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

[40653405008607]

Moist Heat or Steam Sterilization

[40653405008607]

Moist Heat or Steam Sterilization

[40653405008607]

Moist Heat or Steam Sterilization

[40653405008607]

Moist Heat or Steam Sterilization

[40653405008607]

Moist Heat or Steam Sterilization

[40653405008607]

Moist Heat or Steam Sterilization

[40653405008607]

Moist Heat or Steam Sterilization

[40653405008607]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-24

Devices Manufactured by Conmed Corporation

• 30653405987585 - PlumeSafe® X5™: 2024-10-22 PlumeSafe® X5™ Smoke Evacuation Unit, 220V-240V 50/60 Hz
• 30653405987592 - PlumeSafe® X5™: 2024-10-22 PlumeSafe® X5™ Smoke Evacuation Unit with PlumeSafe® X5™ Smoke Evacuator Filter, 220V-240V 50/60 Hz
• 30653405987608 - PlumeSafe® X5™: 2024-10-22 PlumeSafe® X5™ Smoke Evacuation Unit, 220V-240V 50/60 Hz
• 30653405990141 - PlumeSafe® X5™: 2024-10-22 PlumeSafe® X5™ Smoke Evacuation Unit with PlumeSafe® X5™ Smoke Evacuator Filter, 220V-240V 50/60 Hz
• 20653405990120 - BioBrace: 2024-09-30 BioBrace® Reinforced Implant, 23 x 25 mm
• 20653405990137 - BioBrace: 2024-09-30 BioBrace® Reinforced Implant, 35 x 25 mm
• 20653405990144 - BioBrace: 2024-09-30 BioBrace® Reinforced Implant, 40 x 60 mm
• 20653405990151 - BioBrace: 2024-09-30 BioBrace® Reinforced Implant, Foot & Ankle, 40 x 60 mm