Catalog Number

412012

Brand Name

AQUACEL AG

Version/Model Number

412012

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

-

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

000ca50a-3297-4180-a5c3-c494638d3edf

Public Version Date

May 23, 2022

Public Version Number

7

DI Record Publish Date

August 22, 2016

Package DI Number

00768455111251

Quantity per Package

10

Contains DI Package

00768455124275

Package Discontinue Date

May 20, 2022

Package Status

Not in Commercial Distribution

Package Type

Carton