FiberStitch™ Implant, 24° Curve with two Polyester Implants and 2-0 FiberWire® S 174000ar

GUDID 10818674025703

T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION

Soft-tissue/mesh anchor, non-bioabsorbable
Primary Device ID10818674025703
NIH Device Record Key3b81ef92-0942-4e72-85db-de73c823ff09
Commercial Distribution StatusIn Commercial Distribution
Brand NameFiberStitch™ Implant, 24° Curve with two Polyester Implants and 2-0 FiberWire® S
Version Model NumberAR-4570-24
Catalog Number174000ar
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
GS110818674025703 [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 Date2020-10-26
Device Publish Date2020-10-18

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

10810190016234 - Guide Wire Inserter2024-12-23
10810128460610 - TruFire™ 2024-11-06 TruFire™ Suture Passer with Non-Ratcheting Handle
10810128460627 - TruFire™ 2024-11-06 TruFire™ Suture Passer with Ratcheting Handle
10810128460603 - TruFire™ 2024-11-06 TruFire™ Suture Passer Needle
10810128461006 - HydroSeal™ 2024-10-07 HydroSeal™ Silicone Cannula 8mm x 20mm
10810128461013 - HydroSeal™ 2024-10-07 HydroSeal™ Silicone Cannula 8mm x 30mm
10810128461020 - HydroSeal™ 2024-10-07 HydroSeal™ Silicone Cannula 8mm x 50mm
10810128461037 - HydroSeal™ 2024-10-07 HydroSeal™ Silicone Cannula 12mm x 40mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.