Duns Number:081362926
Device Description: The Revive reusable bladder support is intended for temporary management of urinary leakag The Revive reusable bladder support is intended for temporary management of urinary leakage caused by stress urinary incontinence (SUI) in women, 18 years and older.
Catalog Number
0025
Brand Name
Revive
Version/Model Number
0025
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K183468,K183468,K183468,K183468
Product Code
HHW
Product Code Name
Pessary, Vaginal
Public Device Record Key
3e1a4340-7ee8-4073-9dc2-288285337dc5
Public Version Date
April 12, 2019
Public Version Number
1
DI Record Publish Date
April 04, 2019
Package DI Number
20854389008027
Quantity per Package
6
Contains DI Package
10854389008020
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |