Navigation Pin HTZ-2P-000-10

GUDID 84053613292050

Gebr. Brasseler GmbH & Co. KG

Orthopaedic intraoperative positioning pin, single-use

• Primary Device ID: 84053613292050
• NIH Device Record Key: 7ae3d5ca-fbaa-47f3-9b9c-54e265361f5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigation Pin
• Version Model Number: HTZ-2P-000-10
• Catalog Number: HTZ-2P-000-10
• Company DUNS: 317409001
• Company Name: Gebr. Brasseler GmbH & Co. KG
• Device Count: 2
• 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	14053613292051 [Primary]
GS1	84053613292050 [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: 2024-10-21
• Device Publish Date: 2024-10-12

On-Brand Devices [Navigation Pin]

• 24053613287214: GS910.080.032.M5
• 24053613287344: 170-00-002
• 24053613291976: HTS-2P-44140
• 24053613291969: HTS-2P-44110
• 24053613291952: HTS-2P-13527
• 24053613292065: HTZ-2P-000-11
• 84053613292050: HTZ-2P-000-10
• 24053613291983: HTS-2P-44170
• 24053613291884: HTS-2P-03-150
• 24053613291860: HTS-2P-03-100
• 24053613291945: HTS-2P-13524