3811-4-090S

GUDID 07613154711215

Steinmann Pin Trocar Point

Stryker Trauma SA

Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 07613154711215
• NIH Device Record Key: d6984179-e853-412e-a38e-d2ae28baf639
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 3811-4-090S
• Catalog Number: 3811-4-090S
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	07613154711215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211508

FDA Product Code

• HTY: PIN, FIXATION, SMOOTH
• JDW: PIN, FIXATION, THREADED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-03-08
• Device Publish Date: 2023-01-24

Devices Manufactured by Stryker Trauma SA

• 07613327555554 - VARIAX: 2024-10-30 T-handle, Cannulated Three-jaw Chuck
• 07613327605808 - PANGEA: 2024-10-18 Small Frag. Proximal Tibia Targeter Tray
• 07613327603101 - REUNION: 2024-10-09 Modular Glenoid Surface Trial
• 07613327603118 - REUNION: 2024-10-09 Modular Glenoid Surface Trial
• 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