Duns Number:543740310
Catalog Number
KPRO20
Brand Name
KerraPro
Version/Model Number
4 x 4 x 0.5in
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMP
Product Code Name
Protector, Skin Pressure
Public Device Record Key
dcf26d5d-235c-4621-a6e8-fc0b27181e64
Public Version Date
September 09, 2020
Public Version Number
2
DI Record Publish Date
October 01, 2019
Package DI Number
05060077230392
Quantity per Package
5
Contains DI Package
05060077230446
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 29 |
U | Unclassified | 7 |