Catalog Number

420807

Brand Name

AQUACEL AG FOAM

Version/Model Number

420807

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

K123481,K123481,K123481

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

164afa21-a230-437c-8a9d-3d9740394979

Public Version Date

July 22, 2021

Public Version Number

5

DI Record Publish Date

September 15, 2016

Package DI Number

00768455129218

Quantity per Package

5

Contains DI Package

00768455129201

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton