Catalog Number

421579

Brand Name

AQUACEL FOAM PRO

Version/Model Number

421579

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

NAC

Product Code Name

Dressing,Wound,Hydrophilic

Public Device Record Key

b66fdbac-e6b7-4f38-bb26-16cec1590ac5

Public Version Date

July 22, 2021

Public Version Number

4

DI Record Publish Date

August 22, 2016

Package DI Number

00768455140534

Quantity per Package

5

Contains DI Package

00768455140510

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton