AQUACEL AG FOAM - AQUACEL FOAM AG N/ADH 20X20(1X5) NAI - CONVATEC, PURCHASING DEPARTMENT

Duns Number:809784593

Device Description: AQUACEL FOAM AG N/ADH 20X20(1X5) NAI

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

420646

Brand Name

AQUACEL AG FOAM

Version/Model Number

420646

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K123481,K123481,K123481

Product Code Details

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

6eb6ae28-01cf-43eb-ae38-92525dd3192e

Public Version Date

July 22, 2021

Public Version Number

5

DI Record Publish Date

August 22, 2016

Additional Identifiers

Package DI Number

00768455123681

Quantity per Package

5

Contains DI Package

00768455123902

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"CONVATEC, PURCHASING DEPARTMENT" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 116
U Unclassified 8