Duns Number:017524666
Device Description: Silicone Scar Removal Sheets, (40x60x0.5mm / 1.5 x 2.4"). Light Tan color. Non-sterile.
Catalog Number
SCS-T1R
Brand Name
Wound Free
Version/Model Number
SCS-T1R
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)
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
ed03e24b-00fa-407a-8ee2-b592ecf889d0
Public Version Date
May 30, 2022
Public Version Number
1
DI Record Publish Date
May 20, 2022
Package DI Number
10814639025481
Quantity per Package
10
Contains DI Package
00814639025484
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 121 |