Duns Number:305524696
Device Description: Brava Skin Barrier Wipe.
Catalog Number
120215
Brand Name
Brava
Version/Model Number
120215
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EXB
Product Code Name
COLLECTOR, OSTOMY
Public Device Record Key
8bcbd5ca-90f5-482f-ab60-2a85d15ee214
Public Version Date
May 16, 2022
Public Version Number
1
DI Record Publish Date
May 06, 2022
Package DI Number
05708932500968
Quantity per Package
30
Contains DI Package
05708932674706
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Retail Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 46 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 899 |
| 3 | A medical device with high risk that requires premarket approval | 72 |
| U | Unclassified | 7 |