GYNECARE TVT 810081L

GUDID 10705031062306

Obturator system, Tension-free support for incontinence

Ethicon Sàrl

Stress urinary incontinence surgical mesh, female
Primary Device ID10705031062306
NIH Device Record Key4244a691-22bb-4255-9e28-e9a0eb2178ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameGYNECARE TVT
Version Model Number810081L
Catalog Number810081L
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
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
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged

Device Identifiers

Device Issuing AgencyDevice ID
GS110705031062306 [Primary]
GS120705031062303 [Package]
Package: BOX [1 Units]
In Commercial Distribution

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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