Guide Pins & Guide Screws GP002.070.032.

GUDID 84053613290995

Gebr. Brasseler GmbH & Co. KG

Orthopaedic intraoperative positioning pin, single-use

• Primary Device ID: 84053613290995
• NIH Device Record Key: c160da2a-cc11-40bb-b261-cb73b970959d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guide Pins & Guide Screws
• Version Model Number: GP002.070.032..K4
• Catalog Number: GP002.070.032.
• Company DUNS: 317409001
• Company Name: Gebr. Brasseler GmbH & Co. KG
• Device Count: 20
• DM Exempt: true
• 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	14053613290996 [Primary]
GS1	84053613290995 [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

[84053613290995]

Moist Heat or Steam Sterilization

[84053613290995]

Moist Heat or Steam Sterilization

[84053613290995]

Moist Heat or Steam Sterilization

[84053613290995]

Moist Heat or Steam Sterilization

[84053613290995]

Moist Heat or Steam Sterilization

[84053613290995]

Moist Heat or Steam Sterilization

[84053613290995]

Moist Heat or Steam Sterilization

[84053613290995]

Moist Heat or Steam Sterilization

[84053613290995]

Moist Heat or Steam Sterilization

[84053613290995]

Moist Heat or Steam Sterilization

[84053613290995]

Moist Heat or Steam Sterilization

[84053613290995]

Moist Heat or Steam Sterilization

[84053613290995]

Moist Heat or Steam Sterilization

[84053613290995]

Moist Heat or Steam Sterilization

[84053613290995]

Moist Heat or Steam Sterilization

[84053613290995]

Moist Heat or Steam Sterilization

[84053613290995]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-16
• Device Publish Date: 2024-07-08

On-Brand Devices [Guide Pins & Guide Screws]

• 24053613285555: PN-32089-04K
• 84053613290995: GP002.070.032..K4