Betta Link Knotless - Implant Kit 180100bsm

GUDID 10818674028780

T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID10818674028780
NIH Device Record Key8d0589c2-a4c4-4922-a4f2-b6ed93352aff
Commercial Distribution StatusIn Commercial Distribution
Brand NameBetta Link Knotless - Implant Kit
Version Model Number110045154
Catalog Number180100bsm
Company DUNS534123013
Company NameT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110818674028780 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-08
Device Publish Date2025-03-31

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

10818674028773 - Betta Link Knotless - Implant Only2025-04-08
10818674028780 - Betta Link Knotless - Implant Kit2025-04-08
10818674028780 - Betta Link Knotless - Implant Kit2025-04-08
10818674028797 - Betta Link Disposable Hard Bone Drill Bit 2025-04-08
10818674028803 - Betta Link Disposable Soft Bone Drill Bit2025-04-08
10818674028810 - Betta Link Knotless Long - Implant Only2025-04-08
10818674028827 - Betta Link Knotless Long - Implant Kit2025-04-08
10818674028834 - Betta Link Long Disposable Hard Bone Drill Bit2025-04-08
10818674028841 - Betta Link Reusable Pronged Guide2025-04-08

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.