GYNECARE TVT 810061

GUDID 10705031062245

Reusable Rigid Catheter Guide

Ethicon Sàrl

Urethral manipulator Urethral manipulator Urethral manipulator Urethral manipulator Urethral manipulator Urethral manipulator Urethral manipulator Urethral manipulator Urethral manipulator Urethral manipulator
Primary Device ID10705031062245
NIH Device Record Key2835edad-a53d-41df-80f3-f8ac8a8a3247
Commercial Distribution StatusIn Commercial Distribution
Brand NameGYNECARE TVT
Version Model Number810061
Catalog Number810061
Company DUNS480920383
Company NameEthicon Sàrl
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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
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
GS110705031062245 [Primary]

FDA Product Code

KOASURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10705031062245]

Moist Heat or Steam Sterilization


[10705031062245]

Moist Heat or Steam Sterilization


[10705031062245]

Moist Heat or Steam Sterilization


[10705031062245]

Moist Heat or Steam Sterilization


[10705031062245]

Moist Heat or Steam Sterilization


[10705031062245]

Moist Heat or Steam Sterilization


[10705031062245]

Moist Heat or Steam Sterilization


[10705031062245]

Moist Heat or Steam Sterilization


[10705031062245]

Moist Heat or Steam Sterilization


[10705031062245]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-20
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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