Duns Number:344089540
Device Description: Suprathel® is an absorbable, microporous membrane and alloplastic skin substitute for the
Catalog Number
111823-US, 151823-US
Brand Name
Suprathel®
Version/Model Number
Suprathel 18x23
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K090160,K090160,K090160
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
bcb0a24c-3c86-4b28-ba65-8a1d1d46802b
Public Version Date
September 27, 2021
Public Version Number
1
DI Record Publish Date
September 17, 2021
Package DI Number
04260184021475
Quantity per Package
1
Contains DI Package
04260184021437
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton envelope
Device Class | Device Class Description | No of Devices |
---|---|---|
U | Unclassified | 11 |