97.10215

GUDID 20845854025953

3.4MM X 130MM SUTURE HOOK, CORKSCREW RIGHT

Conmed Corporation

Soft-tissue surgical hook, reusable Soft-tissue surgical hook, reusable Soft-tissue surgical hook, reusable Soft-tissue surgical hook, reusable Soft-tissue surgical hook, reusable Soft-tissue surgical hook, reusable Soft-tissue surgical hook, reusable Soft-tissue surgical hook, reusable

• Primary Device ID: 20845854025953
• NIH Device Record Key: 5984106f-d909-4529-865e-eb1cb47acd43
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 97.10215
• Catalog Number: 97.10215
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

• Width: 3.4 Millimeter
• Length: 130 Millimeter
• Width: 3.4 Millimeter
• Length: 130 Millimeter
• Width: 3.4 Millimeter
• Length: 130 Millimeter
• Width: 3.4 Millimeter
• Length: 130 Millimeter
• Width: 3.4 Millimeter
• Length: 130 Millimeter
• Width: 3.4 Millimeter
• Length: 130 Millimeter
• Width: 3.4 Millimeter
• Length: 130 Millimeter
• Width: 3.4 Millimeter
• Length: 130 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10845854025956 [Primary]
GS1	20845854025953 [Direct Marking]

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[20845854025953]

Moist Heat or Steam Sterilization

[20845854025953]

Moist Heat or Steam Sterilization

[20845854025953]

Moist Heat or Steam Sterilization

[20845854025953]

Moist Heat or Steam Sterilization

[20845854025953]

Moist Heat or Steam Sterilization

[20845854025953]

Moist Heat or Steam Sterilization

[20845854025953]

Moist Heat or Steam Sterilization

[20845854025953]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-07-04
• Device Publish Date: 2020-09-24

Devices Manufactured by Conmed Corporation

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• 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