60-0860-001

GUDID 40653405008577

FINE NEEDLE ELECTROSURGICAL ELECTRODE

Conmed Corporation

Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use

• Primary Device ID: 40653405008577
• NIH Device Record Key: 8c2bdfdd-0611-47d1-83ae-7b52d6d6c363
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 60-0860-001
• Catalog Number: 60-0860-001
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00653405008579 [Unit of Use]
GS1	20653405008573 [Package]; Contains: 30653405008570; Package: BAG [6 Units]; In Commercial Distribution
GS1	30653405008570 [Primary]
GS1	40653405008577 [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

[40653405008577]

Moist Heat or Steam Sterilization

[40653405008577]

Moist Heat or Steam Sterilization

[40653405008577]

Moist Heat or Steam Sterilization

[40653405008577]

Moist Heat or Steam Sterilization

[40653405008577]

Moist Heat or Steam Sterilization

[40653405008577]

Moist Heat or Steam Sterilization

[40653405008577]

Moist Heat or Steam Sterilization

[40653405008577]

Moist Heat or Steam Sterilization

[40653405008577]

Moist Heat or Steam Sterilization

[40653405008577]

Moist Heat or Steam Sterilization

[40653405008577]

Moist Heat or Steam Sterilization

[40653405008577]

Moist Heat or Steam Sterilization

[40653405008577]

Moist Heat or Steam Sterilization

[40653405008577]

Moist Heat or Steam Sterilization

[40653405008577]

Moist Heat or Steam Sterilization

[40653405008577]

Moist Heat or Steam Sterilization

[40653405008577]

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

• 30845854026797 - GENESYS CrossFT, Hi-Fi: 2024-04-25 5.5 mm GENESYS CrossFT Suture Anchor with Three #2 (5 metric) Hi-Fi Sutures
• 30845854026803 - GENESYS CrossFT, Hi-Fi: 2024-04-25 6.5 mm GENESYS CrossFT Suture Anchor with Two #2 (5 metric) Hi-Fi Sutures
• 30845854026810 - GENESYS CrossFT, Hi-Fi: 2024-04-25 6.5 mm GENESYS CrossFT Suture Anchor with Three #2 (5 metric) Hi-Fi Sutures
• 30845854027862 - GENESYS PressFT, Hi-Fi: 2024-04-25 GENESYS PressFT 2.1 w/One #2 (5 metric) Hi-Fi Suture, HIP (1 White/Black)
• 30845854027893 - GENESYS PressFT, Hi-Fi: 2024-04-25 GENESYS PressFT 2.6 w/One #2 (5 metric) Hi-Fi Suture, HIP (1 White/Black)
• 30845854034600 - GENESYS CrossFT, Hi-Fi: 2024-04-25 GENESYS CrossFT 5.5 mm Suture Anchor, w/3 Hi-Fi #2 (5 metric) Sutures w/Needles
• 30845854034617 - GENESYS CrossFT, Hi-Fi: 2024-04-25 GENESYS CrossFT 6.5 mm Suture Anchor, w/2 Hi-Fi #2 (5 metric) Sutures w/Needles
• 30653405988643 - Argo Knotless GENESYS: 2024-04-22 5.5mm Argo Knotless® GENESYSTM Anchor