Duns Number:216970711
Device Description: Silicone Scar Spray in bottles made from zylinderfl.60, glasklar PETG, 5g, M300 smooth whi Silicone Scar Spray in bottles made from zylinderfl.60, glasklar PETG, 5g, M300 smooth white Spray head. Label material white PP with UV gloss varnish
Catalog Number
SDSCR60
Brand Name
SilDerm Scar Spray
Version/Model Number
60ml
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
28d2748b-f7e2-44f3-99d1-df938dd73853
Public Version Date
September 08, 2020
Public Version Number
1
DI Record Publish Date
August 31, 2020
Package DI Number
25060295490107
Quantity per Package
12
Contains DI Package
15060295490100
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner