Duns Number:657476292
Device Description: Anscare Leniscar Silicone Stick provides an easy-to-use topical scar treatment. It is inte Anscare Leniscar Silicone Stick provides an easy-to-use topical scar treatment. It is intended to diminish hypertrophic scars and keloids characterized with a raised or discolored appearance. LeniScar is an advanced silicone formula which contains medical grade silicone and antioxidant vitamin C & E. It creates a waterproof, transparent thinfilm which helps to maintain the moisture balance of skin and provides an optimal protective barrier for the scar to restore.
Catalog Number
-
Brand Name
Anscare LeniScar Silicone Stick
Version/Model Number
SP-200-2
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
9bea3139-6d6e-41db-a8d6-2fc5628cd53f
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 |