Duns Number:480920383
Device Description: Obturator system, Tension-free support for incontinence
Catalog Number
810081L
Brand Name
GYNECARE TVT
Version/Model Number
810081L
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OTN
Product Code Name
mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
Public Device Record Key
4244a691-22bb-4255-9e28-e9a0eb2178ad
Public Version Date
June 10, 2022
Public Version Number
9
DI Record Publish Date
September 23, 2015
Package DI Number
20705031062303
Quantity per Package
1
Contains DI Package
10705031062306
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |
| 3 | A medical device with high risk that requires premarket approval | 11 |