Catalog Number

-

Brand Name

Phoenix Wound Matrix

Version/Model Number

FG-0013

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

3e94bfe5-0db4-4d6e-b7f8-3e9d15b751b1

Public Version Date

August 09, 2021

Public Version Number

3

DI Record Publish Date

August 22, 2019

Package DI Number

20852513007083

Quantity per Package

5

Contains DI Package

10852513007086

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case