Duns Number:305524696
Device Description: Brava Protective Seal. Feel Secure. Qty. Thickness 4.2 mm, Diameter Inner 34 mm, Diameter Brava Protective Seal. Feel Secure. Qty. Thickness 4.2 mm, Diameter Inner 34 mm, Diameter Inner 1 3/8 in, Diameter Outer 64 mm, Diameter Outer 2 1/2 in.
Catalog Number
12049
Brand Name
Brava
Version/Model Number
12049
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)
-
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
6aef742e-1bce-4ed1-84e3-0705416058da
Public Version Date
April 18, 2022
Public Version Number
1
DI Record Publish Date
April 08, 2022
Package DI Number
05708932016254
Quantity per Package
48
Contains DI Package
05708932016155
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper 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 |