Duns Number:021717889
Device Description: Transvaginal Fit Mid-Urethral Sling
Catalog Number
-
Brand Name
Conservia™
Version/Model Number
M0068502310
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 30, 2018
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
-
Product Code
OTN
Product Code Name
mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
Public Device Record Key
d53e8fbb-31d4-4a68-988f-a0f2f61c0d2b
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
November 05, 2015
Package DI Number
08714729887546
Quantity per Package
5
Contains DI Package
08714729856016
Package Discontinue Date
November 30, 2018
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |