GFS Sterile Top Hat la524nt00st

GUDID 10810128461617

T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 10810128461617
• NIH Device Record Key: 01ce7e8d-d919-4cfc-864d-93afdf639972
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GFS Sterile Top Hat
• Version Model Number: 3910-800-001
• Catalog Number: la524nt00st
• Company DUNS: 534123013
• Company Name: T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
• Device Count: 1
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10810128461617 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110763

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: 2026-01-19
• Device Publish Date: 2026-01-11

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• 10810128461839 - GFS Glenoid Guide: 2026-01-26
• 10810128461846 - GFS Small Probe: 2026-01-26
• 10810128461655 - GFS Switching Stick: 2026-01-23
• 10810128461662 - GFS Inline Coracoid Drill Guide: 2026-01-23