Catalog Number

-

Brand Name

MiroDerm Fenestrated Plus

Version/Model Number

BLM-200-03-0307

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 13, 2022

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

KGN

Product Code Name

Dressing, Wound, Collagen

Public Device Record Key

a4fdae5b-e9a0-48af-8872-46467c5b6bc7

Public Version Date

January 14, 2022

Public Version Number

2

DI Record Publish Date

September 30, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-