Catalog Number

-

Brand Name

DUODERM

Version/Model Number

403328

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

NAD

Product Code Name

Dressing, Wound, Occlusive

Public Device Record Key

496cb3f9-f6c3-4cfc-a115-1d4f4d78d121

Public Version Date

October 18, 2022

Public Version Number

5

DI Record Publish Date

April 12, 2019

Package DI Number

10768455107268

Quantity per Package

10

Contains DI Package

00768455107261

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case