FiberStitch™ Implant 1.5, Curved with two Polyester Implants and 2-0 FiberWire 176200arce

GUDID 10810128461341

FiberStitch™ Implant 1.5, Curved 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 ID10810128461341
NIH Device Record Keyd9f776b5-efd5-46a0-8639-3edf15197d3e
Commercial Distribution StatusIn Commercial Distribution
Brand NameFiberStitch™ Implant 1.5, Curved with two Polyester Implants and 2-0 FiberWire
Version Model NumberAR-4580CE
Catalog Number176200arce
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
GS110810128461341 [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

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

10810128460832 - Portal Entry Kit with FlowPort® Touch, Stryker 165 mm2025-06-26
10810128460849 - FlowPort® Touch, Stryker 165 mm2025-06-26
10810128460863 - Portal Entry Kit with FlowPort® Touch, CL/SZ2025-06-26
10810128460870 - FlowPort® Touch, CL/SZ2025-06-26
10810128460894 - Portal Entry Kit with FlowPort® Touch, Stryker 140mm2025-06-26
10810128460900 - FlowPort® Touch, Stryker 140mm2025-06-26
10810128460924 - Portal Entry Kit with FlowPort® Touch, SN2025-06-26
10810128460931 - FlowPort® Touch, SN2025-06-26

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