Duns Number:216344051
Device Description: Silicone Gel Sheet. Treatment for red and raised, old and new scars
Catalog Number
66250704 & 66250705
Brand Name
CicaCare 12cm x 6cm Ctn of 1 Global
Version/Model Number
66250704
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
MDA
Product Code Name
Elastomer, Silicone, For Scar Management
Public Device Record Key
90e4a968-af06-4573-bdfd-072f10e5a398
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
February 12, 2021
Package DI Number
05000223441784
Quantity per Package
1
Contains DI Package
05000223441586
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 | 63 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 126 |
| U | Unclassified | 1 |