Guide Screw HTZ-2P-035-33

GUDID 24053613292119

Gebr. Brasseler GmbH & Co. KG

Orthopaedic intraoperative positioning pin, single-use

• Primary Device ID: 24053613292119
• NIH Device Record Key: 30554728-9226-4373-bb03-1678887b2dff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guide Screw
• Version Model Number: HTZ-2P-035-33
• Catalog Number: HTZ-2P-035-33
• 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	14053613292112 [Primary]
GS1	24053613292119 [Package]; Contains: 14053613292112; Package: [1 Units]; In Commercial Distribution
GS1	84053613292111 [Unit of Use]

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: 2024-10-21
• Device Publish Date: 2024-10-12

On-Brand Devices [Guide Screw]

• 24053613285951: Guide Screw Ø 3,20mm
• 24053613285920: Guide Screw Ø 3,20mm
• 24053613292119: HTZ-2P-035-33
• 24053613292034: HTZ-2P-025-25
• 24053613292027: HTZ-2P-041-00
• 24053613292010: HTZ-2P-040-48
• 24053613292003: HTZ-2P-040-33
• 24053613291921: HTD-4P-02-302
• 24053613291914: HTD-4P-02-303