1320-5385

GUDID 04546540520388

5 STEP REFERENCE CHART DISTAL TARGETING

Stryker Trauma SA

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 04546540520388
• NIH Device Record Key: 000ccd88-e2be-4734-9317-5eda990a010b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 1320-5385
• Catalog Number: 1320-5385
• Company DUNS: 481999654
• Company Name: Stryker Trauma SA
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	04546540520388 [Primary]

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[04546540520388]

Moist Heat or Steam Sterilization

[04546540520388]

Moist Heat or Steam Sterilization

[04546540520388]

Moist Heat or Steam Sterilization

[04546540520388]

Moist Heat or Steam Sterilization

[04546540520388]

Moist Heat or Steam Sterilization

[04546540520388]

Moist Heat or Steam Sterilization

[04546540520388]

Moist Heat or Steam Sterilization

[04546540520388]

Moist Heat or Steam Sterilization

[04546540520388]

Moist Heat or Steam Sterilization

[04546540520388]

Moist Heat or Steam Sterilization

[04546540520388]

Moist Heat or Steam Sterilization

[04546540520388]

Moist Heat or Steam Sterilization

[04546540520388]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-19
• Device Publish Date: 2024-04-11

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• 07613327603125 - REUNION: 2024-10-09 Modular Glenoid Surface Trial
• 07613327603132 - REUNION: 2024-10-09 Modular Humeral Head Trial
• 07613327603149 - REUNION: 2024-10-09 Modular Glenoid Surface Trial
• 07613327603156 - REUNION: 2024-10-09 Modular Humeral Head Trial