Guide Pin & Guide Screw Set HTD-00-111

GUDID 24053613292096

Gebr. Brasseler GmbH & Co. KG

Orthopaedic intraoperative positioning pin, single-use

• Primary Device ID: 24053613292096
• NIH Device Record Key: a03a6b91-72af-4585-be30-381c01a55fdf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guide Pin & Guide Screw Set
• Version Model Number: HTD-00-111
• Catalog Number: HTD-00-111
• 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	14053613292099 [Primary]
GS1	24053613292096 [Package]; Contains: 14053613292099; 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: 2024-10-21
• Device Publish Date: 2024-10-12

On-Brand Devices [Guide Pin & Guide Screw Set]

• 24053613284374: OC06D.067.032
• 24053613285548: OC06D.076.032
• 24053613287221: GS06D.067.032
• 24053613292096: HTD-00-111