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

Devices Manufactured by Stryker Trauma SA

• 07613252645870 - NA: 2024-07-02 Insert MMT
• 07613252645887 - NA: 2024-07-02 Insert MMT
• 07613327615050 - VARIAX: 2024-05-15 Extended Volar DR Aiming Block, std., R
• 07613327615111 - VARIAX: 2024-05-15 Volar DR Aiming Block, narrow, R
• 07613327615203 - VARIAX: 2024-05-15 Volar DR Aiming Block, standard, R
• 07613327615234 - VARIAX: 2024-05-15 Extended Volar DR Aiming Block, std., L
• 07613327615425 - VARIAX: 2024-05-15 Volar DR Aiming Block, standard, L
• 07613327615517 - VARIAX: 2024-05-15 Volar DR Aiming Block, wide, L