Duns Number:171843584
Device Description: POUCH STER 5.25 X 10 200/BOX
Catalog Number
-
Brand Name
BRAVAL
Version/Model Number
070436824
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
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
KCT
Product Code Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Public Device Record Key
f2767719-e97a-432b-8430-9f88019b768a
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
D6620704368244
Quantity per Package
6
Contains DI Package
D6620704368242
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 16 |
2 | A medical device with a moderate to high risk that requires special controls. | 145 |
U | Unclassified | 9 |