Duns Number:657476292
Device Description: Anscare Scar Reduction Silicone Gel C+ helps prevent and treat both existing and new scars Anscare Scar Reduction Silicone Gel C+ helps prevent and treat both existing and new scars like keloids and hypertrophic scars resulting from surgery, trauma, burns, etc. (External Use Only)
Catalog Number
-
Brand Name
Anscare Scar Reduction Silicone Gel C+
Version/Model Number
SC201-1
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)
Yes
Over the Counter (OTC)
Yes
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
01b76724-f1a9-4815-902d-cc4fe3958f1a
Public Version Date
September 27, 2022
Public Version Number
1
DI Record Publish Date
September 19, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |