Guide Screw Headless Threaded TKR.BB.1500

GUDID 84053613287605

Gebr. Brasseler GmbH & Co. KG

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• Primary Device ID: 84053613287605
• NIH Device Record Key: 34afe067-8bad-4a31-ba35-656d0b553142
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guide Screw Headless Threaded
• Version Model Number: TKR.BB.1500
• Catalog Number: TKR.BB.1500
• Company DUNS: 317409001
• Company Name: Gebr. Brasseler GmbH & Co. KG
• Device Count: 2
• 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	14053613287606 [Primary]
GS1	84053613287605 [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: 2024-02-26
• Device Publish Date: 2024-02-16

On-Brand Devices [Guide Screw Headless Threaded]

• 84053613287636: TKR.IN.1332
• 84053613287629: TKR.IN.1331
• 84053613287612: TKR.IN.1352
• 84053613287605: TKR.BB.1500