Guide Pin Kit 2024-0003

GUDID 24053613292539

Gebr. Brasseler GmbH & Co. KG

Orthopaedic intraoperative positioning pin, single-use

• Primary Device ID: 24053613292539
• NIH Device Record Key: 86de46ea-f1ca-4a26-931d-f0dee5ca692c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guide Pin Kit
• Version Model Number: 2024-0003
• Catalog Number: 2024-0003
• 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	14053613292532 [Primary]
GS1	24053613292539 [Package]; Contains: 14053613292532; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131264

FDA Product Code

• HWC: Screw, Fixation, Bone

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: 2025-02-18
• Device Publish Date: 2025-02-10

Devices Manufactured by Gebr. Brasseler GmbH & Co. KG

• 24053613293390 - Shannon Recta X-Larga: 2025-09-12
• 24053613271725 - KOMET Surgical Bur: 2025-09-10
• 24053613294335 - KOMET Surgical Saw Blade: 2025-09-10
• 24053613292171 - KMS Saw Blade: 2025-09-08
• 24053613292188 - KMS Saw Blade: 2025-09-08
• 24053613292195 - KMS Saw Blade: 2025-09-08
• 24053613292201 - KMS Saw Blade: 2025-09-08
• 24053613292218 - KMS Saw Blade: 2025-09-08