Betta Link LG Knotless Hip Implant KIT 180200bsm

GUDID 10818674025772

T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 10818674025772
• NIH Device Record Key: 393155ba-fc96-40ea-9c90-88343afc122c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Betta Link LG Knotless Hip Implant KIT
• Version Model Number: 110045160
• Catalog Number: 180200bsm
• 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: true
• 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	10818674025772 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210498

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

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: 2022-02-10
• Device Publish Date: 2022-02-02

Devices Manufactured by T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION

• 10810128460009 - Rounger Raptor Straight shaft: 2025-01-17
• 10810128460016 - Grasping Forceps 1x2 teeth Straight shaft: 2025-01-17
• 10810128460023 - Grasping Forceps Alligator Straight shaft, jaw wide 2.7mm: 2025-01-17
• 10818674026304 - Knotless flush cutter: 2025-01-17
• 10818674026502 - Suture cutter 2.0: 2025-01-17
• 10818674029756 - Duckbee Basket Punch, small Straight shaft: 2025-01-17
• 10818674029763 - Duckbee Basket Punch, small, upbiter Straight shaft: 2025-01-17
• 10818674029770 - Duckbee Basket Punch, medium Straight shaft: 2025-01-17