Tech Knee Pack 150-00-001

GUDID 14053613294574

Gebr. Brasseler GmbH & Co. KG

Orthopaedic intraoperative positioning pin, single-use

• Primary Device ID: 14053613294574
• NIH Device Record Key: bc9e224d-ffda-4bff-83ee-99e5b3548709
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tech Knee Pack
• Version Model Number: 150-00-001
• Catalog Number: 150-00-001
• Company DUNS: 317409001
• Company Name: Gebr. Brasseler 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: 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	14053613294574 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131264

FDA Product Code

• JDW: Pin, Fixation, Threaded

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-14
• Device Publish Date: 2026-01-06

Devices Manufactured by Gebr. Brasseler GmbH & Co. KG

• 24053613295721 - Shannon Recta X-Larga: 2026-02-02
• 24053613284978 - Saw Blade: 2026-01-29 Reciprocating saw blade
• E226048483R18 - KOMET Root Canal Files: 2026-01-21
• 14053613294581 - Tech Ancillary Pack: 2026-01-16
• 24053613294557 - Guide Drill Pin: 2026-01-14
• 14053613294574 - Tech Knee Pack: 2026-01-14
• 14053613294574 - Tech Knee Pack: 2026-01-14
• E226007158R18 - KOMET Root Canal Files: 2025-12-18
• E226007159R18 - KOMET Root Canal Files: 2025-12-18