FiberStitch™ Implant, Curved with two Polyester Implants and 2-0 FiberWire® Sutu 171000ar

GUDID 10818674021798

T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION

Soft-tissue/mesh anchor, non-bioabsorbable
Primary Device ID10818674021798
NIH Device Record Key63612b7f-c25f-4bcb-bbdb-ce057c7dd18a
Commercial Distribution StatusIn Commercial Distribution
Brand NameFiberStitch™ Implant, Curved with two Polyester Implants and 2-0 FiberWire® Sutu
Version Model NumberAR-4570
Catalog Number171000ar
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
GS110818674021798 [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 Number3
Public Version Date2020-10-19
Device Publish Date2019-10-11

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