Navigation Pin GS910.080.032

GUDID 24053613287214

Gebr. Brasseler GmbH & Co. KG

Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use

• Primary Device ID: 24053613287214
• NIH Device Record Key: cfb4c1d7-ae0c-43a8-9058-603660a7e064
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigation Pin
• Version Model Number: GS910.080.032.M5
• Catalog Number: GS910.080.032
• Company DUNS: 317409001
• Company Name: Gebr. Brasseler GmbH & Co. KG
• Device Count: 2
• DM Exempt: true
• 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: 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	14053613287217 [Primary]
GS1	24053613287214 [Package]; Contains: 14053613287217; Package: [1 Units]; In Commercial Distribution
GS1	84053613287216 [Unit of Use]

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: 2023-10-09
• Device Publish Date: 2023-09-29

Devices Manufactured by Gebr. Brasseler GmbH & Co. KG

• 24053613288457 - Replacement Offset Saw Blade: 2024-05-10
• 14053613288467 - Replacement Precision Micro Saw Blade: 2024-05-10
• 24053613288488 - Replacement Saw Blade: 2024-05-10
• 24053613288495 - Replacement Offset Saw Blade: 2024-05-10
• 24053613288501 - Replacement Offset Saw Blade: 2024-05-10
• 24053613288518 - Replacement Offset Saw Blade: 2024-05-10
• 24053613288525 - Replacement Offset Saw Blade: 2024-05-10
• 24053613288532 - Replacement Offset Saw Blade: 2024-05-10