LINK Instruments - Drills, reamers and saw blades

GUDID 04026575397570

Orthopaedic prosthesis instrument, reusable - General Instrument

WALDEMAR LINK GmbH & Co. KG

Fluted surgical drill bit, single-use

• Primary Device ID: 04026575397570
• NIH Device Record Key: 812022ea-323e-42af-aff7-1ea384613b83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LINK Instruments - Drills, reamers and saw blades
• Version Model Number: 16-3202/00
• Company DUNS: 315675488
• Company Name: WALDEMAR LINK GmbH & Co. KG
• Device Count: 1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04026575397570 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151008

FDA Product Code

• KRO: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

[04026575397570]

Moist Heat or Steam Sterilization

[04026575397570]

Moist Heat or Steam Sterilization

[04026575397570]

Moist Heat or Steam Sterilization

[04026575397570]

Moist Heat or Steam Sterilization

[04026575397570]

Moist Heat or Steam Sterilization

[04026575397570]

Moist Heat or Steam Sterilization

[04026575397570]

Moist Heat or Steam Sterilization

[04026575397570]

Moist Heat or Steam Sterilization

[04026575397570]

Moist Heat or Steam Sterilization

[04026575397570]

Moist Heat or Steam Sterilization

[04026575397570]

Moist Heat or Steam Sterilization

[04026575397570]

Moist Heat or Steam Sterilization

[04026575397570]

Moist Heat or Steam Sterilization

[04026575397570]

Moist Heat or Steam Sterilization

[04026575397570]

Moist Heat or Steam Sterilization

[04026575397570]

Moist Heat or Steam Sterilization

[04026575397570]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-05
• Device Publish Date: 2023-04-27

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