Duns Number:130341956
Device Description: Desara Blue TVez 3.0mm for the treatment of female stress urinary incontinence (SUI) or mi Desara Blue TVez 3.0mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence
Catalog Number
-
Brand Name
Desara Blue TVez 3.0
Version/Model Number
CAL-DS01BTV30
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
K211975
Product Code
OTN
Product Code Name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Public Device Record Key
95332348-6fb2-4f8c-b830-22a99f9d22a4
Public Version Date
July 19, 2022
Public Version Number
3
DI Record Publish Date
November 15, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 31 |