Catalog Number

420827

Brand Name

AQUACEL AG FOAM

Version/Model Number

420827

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 20, 2022

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

K123481,K123481,K123481

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

02da1afb-f41a-48fc-92b6-a7c61cf5d1e4

Public Version Date

May 23, 2022

Public Version Number

6

DI Record Publish Date

August 22, 2016

Package DI Number

00768455133482

Quantity per Package

5

Contains DI Package

00768455133468

Package Discontinue Date

May 20, 2022

Package Status

Not in Commercial Distribution

Package Type

Carton