Duns Number:830384223
Catalog Number
-
Brand Name
Phoenix Wound Matrix
Version/Model Number
FG-0003
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
-
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
eb20deea-79ad-40d9-b6cb-a4faf3d7a92a
Public Version Date
August 09, 2021
Public Version Number
5
DI Record Publish Date
September 11, 2018
Package DI Number
10852513007031
Quantity per Package
5
Contains DI Package
00852513007034
Package Discontinue Date
September 17, 2019
Package Status
Not in Commercial Distribution
Package Type
Shelf Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |
U | Unclassified | 18 |