Duns Number:543740310
Catalog Number
CWL1135
Brand Name
KerraFoam Gentle Border
Version/Model Number
7 x 8in
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAD
Product Code Name
Dressing, Wound, Occlusive
Public Device Record Key
e4d8702b-baf2-4e91-9c83-5621f7178820
Public Version Date
June 22, 2021
Public Version Number
4
DI Record Publish Date
October 01, 2019
Package DI Number
05060077232617
Quantity per Package
9
Contains DI Package
05060077232600
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
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 |