Duns Number:014302733
Device Description: Scar Fx Silicone Sheeting 1.5"x5"
Catalog Number
11505
Brand Name
Scar Fx
Version/Model Number
11505
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
c12ff088-e1cc-4b2c-a0fa-0ca9c7ff64a8
Public Version Date
August 10, 2020
Public Version Number
1
DI Record Publish Date
July 31, 2020
Package DI Number
00642790245058
Quantity per Package
1
Contains DI Package
00642790115054
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Unit Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 7 |