Duns Number:344089540
Device Description: Suprathel® is an absorbable, microporous membrane and alloplastic skin substitute for the Suprathel® is an absorbable, microporous membrane and alloplastic skin substitute for the treatment of wounds, split-skin donor sites, and burns as indicated hereinafter. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient’s needs.
Catalog Number
12H001-US
Brand Name
Suprathel®
Version/Model Number
Suprathel Hand Size
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
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
f20d63b8-b2d9-4a9b-9fba-9a5266a92fd7
Public Version Date
September 27, 2021
Public Version Number
1
DI Record Publish Date
September 17, 2021
Package DI Number
04260184021567
Quantity per Package
2
Contains DI Package
04260184021543
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton envelope
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| U | Unclassified | 11 |