5195-0-010

GUDID 07613327073713

Body Assembly Dynamic Joint Distractor II

Stryker Trauma SA

Cannulated surgical drill bit, reusable

• Primary Device ID: 07613327073713
• NIH Device Record Key: beaf9ea6-6835-4b5e-80ce-a1c4d0dc6b9a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 5195-0-010
• Catalog Number: 5195-0-010
• Company DUNS: 481999654
• Company Name: Stryker Trauma SA
• 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: 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	07613327073713 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002923

FDA Product Code

• LXT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE

Sterilization

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

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

[07613327073713]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-09-24

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• 07613327603156 - REUNION: 2024-10-09 Modular Humeral Head Trial