Catalog Number

403779

Brand Name

AQUACEL AG BURN

Version/Model Number

403779

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

3078a167-b33b-448a-b8e5-805941f2aca0

Public Version Date

October 21, 2022

Public Version Number

3

DI Record Publish Date

September 05, 2022

Package DI Number

00768455109975

Quantity per Package

3

Contains DI Package

00768455124107

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton