Duns Number:810330282
Device Description: "WoundGelHA MatrixTM is formulated to provide wound care dressing and management. WoundGel "WoundGelHA MatrixTM is formulated to provide wound care dressing and management. WoundGelHA MatrixTM is a combination of emollients and sodium hyaluronate which function to maintain tissue hydration and support the healing process. WoundGelHA MatrixTM has been demonstrated to be of value in the management of certain skin ulcers.Sodium hyaluronate is a salt of hyaluronic acid, a naturally occurring molecule found in various body tissues. The sodium hyaluronate present in WoundGelHA MatrixTM is derived from synthetic sources. "
Catalog Number
-
Brand Name
Wound GelHA Matrix
Version/Model Number
One, 1/3 oz. Tube
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
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
a929e866-3784-44c8-af85-7210be665fc9
Public Version Date
May 23, 2022
Public Version Number
1
DI Record Publish Date
May 13, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| U | Unclassified | 3 |