Duns Number:344089540
Device Description: SupraSDRM® is an absorbable, microporous biodegradable matrix indicated for the management SupraSDRM® is an absorbable, microporous biodegradable matrix indicated for the management of superficial dermal wounds, split-skin graft donor sites, pressure and venous ulcers, and 2nd degree burns. The biodegradable matrix is designed for trauma and surgical wounds involving soft tissues. The SupraSDRM matrix is available in various sizes for use in covering and protecting superficial and partial thickness soft tissue wounds.
Catalog Number
311818-US
Brand Name
SupraSDRM®
Version/Model Number
SupraSDRM 18x18
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
K170213,K170213
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
74531f60-253c-4129-93a5-facf588a1e70
Public Version Date
September 27, 2021
Public Version Number
1
DI Record Publish Date
September 17, 2021
Package DI Number
04260184023424
Quantity per Package
1
Contains DI Package
04260184023431
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| U | Unclassified | 11 |