GYNECARE TVT 810041A

GUDID 10705031062283

Abdominal Guides

Ethicon Sàrl

Stress urinary incontinence surgical mesh, female
Primary Device ID10705031062283
NIH Device Record Key7f835a2f-9e69-4823-8aa7-7498bd15ddaf
Commercial Distribution StatusIn Commercial Distribution
Brand NameGYNECARE TVT
Version Model Number810041A
Catalog Number810041A
Company DUNS480920383
Company NameEthicon Sàrl
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx
Phone+1(877)384-4266
Emailxxx@xxx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
GS110705031062283 [Primary]

FDA Product Code

OTNmesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-05-04
Device Publish Date2015-09-23

On-Brand Devices [GYNECARE TVT]

10705031062306Obturator system, Tension-free support for incontinence
10705031062290Tension-free support, Blue Polypropylene Mesh Tape
10705031062283Abdominal Guides
10705031062245Reusable Rigid Catheter Guide
10705031062238Reusable Introducer
10705031000346Tension-free support for incontinence
10705031000322Tension-free support, Blue Polypropylene Mesh Tape

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