LINK Instruments - Saw and drill guides

GUDID 04026575399680

Orthopaedic implant aiming/guiding block, reusable - Megasystem-C Tumor- and Revision System

WALDEMAR LINK GmbH & Co. KG

Orthopaedic implant aiming/guiding block, reusable

• Primary Device ID: 04026575399680
• NIH Device Record Key: 077e6c06-55f0-41fe-a23f-bcd81ca5e0f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LINK Instruments - Saw and drill guides
• Version Model Number: 16-3277/00
• 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	04026575399680 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151008

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

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

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

Moist Heat or Steam Sterilization

[04026575399680]

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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