Betta Link SR Knotless Shoulder IMPLANT ONLY 181100bsm

GUDID 10818674025789

T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID10818674025789
NIH Device Record Key9e067553-6143-4f7d-88df-53f5dd7856aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameBetta Link SR Knotless Shoulder IMPLANT ONLY
Version Model Number110045149
Catalog Number181100bsm
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 Kitfalse
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
GS110818674025789 [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 Date2022-02-10
Device Publish Date2022-02-02

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