LINK Instruments - Fixation instruments

GUDID 04026575431571

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile - Gemini SL Total Knee System

WALDEMAR LINK GmbH & Co. KG

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: 04026575431571
• NIH Device Record Key: 57f48f9d-b3e9-4909-92df-765dc8f05e60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LINK Instruments - Fixation instruments
• Version Model Number: 319-555/01
• Company DUNS: 315675488
• Company Name: WALDEMAR LINK GmbH & Co. KG
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04026575431571 [Primary]

FDA Product Code

• HXQ: CRIMPER, PIN

Sterilization

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

[04026575431571]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-02-19
• Device Publish Date: 2022-12-14

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