Catalog Number

403771

Brand Name

AQUACEL AG

Version/Model Number

403771

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

K080383,K080383,K080383

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

275a8c84-86a1-4e35-a30f-2616e8dbcdb4

Public Version Date

May 23, 2022

Public Version Number

6

DI Record Publish Date

August 22, 2016

Package DI Number

10768455106742

Quantity per Package

20

Contains DI Package

00768455106745

Package Discontinue Date

May 20, 2022

Package Status

Not in Commercial Distribution

Package Type

CASE