Guide Pin Fluted HP352024

GUDID 84053613292616

Gebr. Brasseler GmbH & Co. KG

Orthopaedic intraoperative positioning pin, single-use

• Primary Device ID: 84053613292616
• NIH Device Record Key: 07a10edf-3771-4870-9222-cca469618b69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guide Pin Fluted
• Version Model Number: HP352024
• Catalog Number: HP352024
• Company DUNS: 317409001
• Company Name: Gebr. Brasseler GmbH & Co. KG
• Device Count: 20
• 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: false
• 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	04053613292610 [Direct Marking]
GS1	14053613292617 [Primary]
GS1	84053613292616 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131264

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[84053613292616]

Moist Heat or Steam Sterilization

[84053613292616]

Moist Heat or Steam Sterilization

[84053613292616]

Moist Heat or Steam Sterilization

[84053613292616]

Moist Heat or Steam Sterilization

[84053613292616]

Moist Heat or Steam Sterilization

[84053613292616]

Moist Heat or Steam Sterilization

[84053613292616]

Moist Heat or Steam Sterilization

[84053613292616]

Moist Heat or Steam Sterilization

[84053613292616]

Moist Heat or Steam Sterilization

[84053613292616]

Moist Heat or Steam Sterilization

[84053613292616]

Moist Heat or Steam Sterilization

[84053613292616]

Moist Heat or Steam Sterilization

[84053613292616]

Moist Heat or Steam Sterilization

[84053613292616]

Moist Heat or Steam Sterilization

[84053613292616]

Moist Heat or Steam Sterilization

[84053613292616]

Moist Heat or Steam Sterilization

[84053613292616]

Moist Heat or Steam Sterilization

[84053613292616]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-05
• Device Publish Date: 2025-04-25

On-Brand Devices [Guide Pin Fluted]

• 84053613292623: HP652024
• 84053613292616: HP352024