Catalog Number

413556

Brand Name

AQUACEL AG SURGICAL

Version/Model Number

413556

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

-

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

50bed448-6bf7-4d7d-9961-e004e0d583cc

Public Version Date

October 20, 2022

Public Version Number

5

DI Record Publish Date

August 22, 2016

Package DI Number

00768455130634

Quantity per Package

10

Contains DI Package

00768455130764

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton