GYNECARE TVT EXACT TVTRL

GUDID 10705031062375

Continence System

Ethicon Sàrl

Stress urinary incontinence surgical mesh, female
Primary Device ID10705031062375
NIH Device Record Key58f65aec-0948-4567-b138-e836b5a3004b
Commercial Distribution StatusIn Commercial Distribution
Brand NameGYNECARE TVT EXACT
Version Model NumberTVTRL
Catalog NumberTVTRL
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
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
GS110705031062375 [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 Number4
Public Version Date2020-05-04
Device Publish Date2015-09-23

Devices Manufactured by Ethicon Sàrl

30705031468089 - SURGICEL NU-KNIT2023-08-07 SURGICEL NU-KNIT Absorbable Hemostats (oxidized regenerated cellulose)
30705031468096 - SURGICEL NU-KNIT2023-05-23 Absorbable Hemostat (oxidized regenerated cellulose)
30705031468102 - SURGICEL2023-05-23 Absorbable Hemostat (oxidized regenerated cellulose)
30705031468119 - SURGICEL2023-05-23 Absorbable Hemostat (oxidized regenerated cellulose)
30705031468126 - SURGICEL2023-05-23 Absorbable Hemostat (oxidized regenerated cellulose)
30705031468133 - SURGICEL2023-05-23 Absorbable Hemostat (oxidized regenerated cellulose)
10705031002975 - SURGICEL NU-KNIT2023-04-24 Absorbable Hemostat (oxidized regenerated cellulose)
20705031003115 - SURGICEL FIBRILLAR2021-02-25 SURGICEL FIBRILLAR Absorbable Hemostats (oxidized regenerated cellulose)

Trademark Results [GYNECARE TVT EXACT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GYNECARE TVT EXACT
GYNECARE TVT EXACT
77912886 4242341 Live/Registered
JOHNSON & JOHNSON
2010-01-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.