Catalog Number

422359

Brand Name

AQUACEL FOAM PRO

Version/Model Number

422359

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)

Yes

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

47d493b4-a57a-4612-8c1b-412e06c44c97

Public Version Date

October 28, 2022

Public Version Number

2

DI Record Publish Date

September 09, 2022

Package DI Number

00768455157303

Quantity per Package

10

Contains DI Package

00768455157341

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton