Catalog Number

403789

Brand Name

AQUACEL AG BURN

Version/Model Number

403789

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

K090254,K090254,K090254

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

0f06a86b-8309-4f6f-8660-04775d4ccce5

Public Version Date

July 22, 2021

Public Version Number

5

DI Record Publish Date

August 22, 2016

Package DI Number

00768455110605

Quantity per Package

3

Contains DI Package

00768455124152

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton