Guide Pin Smooth 800-05-215

GUDID 84053613294535

Gebr. Brasseler GmbH & Co. KG

Orthopaedic intraoperative positioning pin, single-use

• Primary Device ID: 84053613294535
• NIH Device Record Key: 7dd856fb-89f3-4897-b060-cdf708f8aebd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guide Pin Smooth
• Version Model Number: 800-05-215
• Catalog Number: 800-05-215
• 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: 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	04053613294539 [Direct Marking]
GS1	14053613294536 [Primary]
GS1	84053613294535 [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

[84053613294535]

Moist Heat or Steam Sterilization

[84053613294535]

Moist Heat or Steam Sterilization

[84053613294535]

Moist Heat or Steam Sterilization

[84053613294535]

Moist Heat or Steam Sterilization

[84053613294535]

Moist Heat or Steam Sterilization

[84053613294535]

Moist Heat or Steam Sterilization

[84053613294535]

Moist Heat or Steam Sterilization

[84053613294535]

Moist Heat or Steam Sterilization

[84053613294535]

Moist Heat or Steam Sterilization

[84053613294535]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-09
• Device Publish Date: 2026-01-30

Devices Manufactured by Gebr. Brasseler GmbH & Co. KG

• 84053613294535 - Guide Pin Smooth: 2026-02-09
• 84053613294535 - Guide Pin Smooth: 2026-02-09
• 24053613295721 - Shannon Recta X-Larga: 2026-02-02
• 24053613284978 - Saw Blade: 2026-01-29 Reciprocating saw blade
• E226048483R18 - KOMET Root Canal Files: 2026-01-21
• 14053613294581 - Tech Ancillary Pack: 2026-01-16
• 24053613294557 - Guide Drill Pin: 2026-01-14
• 14053613294574 - Tech Knee Pack: 2026-01-14
• E226007158R18 - KOMET Root Canal Files: 2025-12-18