Catalog Number

PFAB-M

Brand Name

PFAB Medium

Version/Model Number

PFAB-M

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 01, 2025

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"

Yes

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

K070457

Product Code

MGP

Product Code Name

Dressing, Wound And Burn, Occlusive

Public Device Record Key

72840547-0e8f-4c2d-9422-1e99f87ffa01

Public Version Date

August 02, 2022

Public Version Number

3

DI Record Publish Date

April 30, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-