Catalog Number

-

Brand Name

MIRRAGEN® Advanced Wound Matrix

Version/Model Number

MES-0101

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K161067,K161067

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

8a5e1bc1-74ea-4070-948a-2d08273df47c

Public Version Date

July 09, 2020

Public Version Number

4

DI Record Publish Date

February 14, 2020

Package DI Number

00812005030117

Quantity per Package

10

Contains DI Package

00812005030087

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box