Guide Pins & Guide Screws PN-32089-04K

GUDID 24053613285555

Gebr. Brasseler GmbH & Co. KG

Intraoperative bone pin/screw

• Primary Device ID: 24053613285555
• NIH Device Record Key: cb534684-2048-4ba4-b514-760fc0a182b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guide Pins & Guide Screws
• Version Model Number: PN-32089-04K
• Catalog Number: PN-32089-04K
• Company DUNS: 317409001
• Company Name: Gebr. Brasseler GmbH & Co. KG
• Device Count: 4
• 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	14053613285558 [Primary]
GS1	24053613285555 [Package]; Contains: 14053613285558; Package: [1 Units]; In Commercial Distribution
GS1	84053613285557 [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: 2023-05-01
• Device Publish Date: 2023-04-21

On-Brand Devices [Guide Pins & Guide Screws]

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