Knotilus Implant Loop, 25mm 500107st

GUDID 30810190010014

T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID30810190010014
NIH Device Record Key29f268bb-33cf-4b28-b849-4177f1621a24
Commercial Distribution StatusIn Commercial Distribution
Brand NameKnotilus Implant Loop, 25mm
Version Model NumberC
Catalog Number500107st
Company DUNS534123013
Company NameT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Device Count5
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 Datefalse
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
GS110810190010010 [Unit of Use]
GS130810190010014 [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 StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-03-21
Device Publish Date2015-09-24

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

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10818674028827 - Betta Link Knotless Long - Implant Kit2025-04-08
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