FiberStitch™ Implant 1.5, Straight with two Polyester Implants and 2-0 Fibe 176100arce

GUDID 10810128461334

FiberStitch™ Implant 1.5, Straight with two Polyester Implants and 2-0 FiberWire® Suture

T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION

Soft-tissue/mesh anchor, non-bioabsorbable
Primary Device ID10810128461334
NIH Device Record Key983ed3af-a0a1-4ca0-852d-70b071be97fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameFiberStitch™ Implant 1.5, Straight with two Polyester Implants and 2-0 Fibe
Version Model NumberAR-4580SCE
Catalog Number176100arce
Company DUNS534123013
Company NameT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
GS110810128461334 [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 Date2025-06-02
Device Publish Date2025-05-25

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10818674026663 - Arthroscopic scissors straight2025-10-03 Arthroscopic scissors straight
10818674026670 - Arthroscopic scissors curved right2025-10-03 Arthroscopic scissors curved right
10818674027288 - Multi Suture Cutter Anika2025-10-03 Multi Suture Cutter Anika
10818674027295 - Sixter Right Anika2025-10-03 Sixter Right Anika
10818674027301 - Sixter Left Anika2025-10-03 Sixter Left Anika

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