Catalog Number

-

Brand Name

DUODERM

Version/Model Number

187971

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

32548273-4355-4e93-8371-5ef12f038687

Public Version Date

October 18, 2022

Public Version Number

5

DI Record Publish Date

March 29, 2019

Package DI Number

10768455102843

Quantity per Package

30

Contains DI Package

00768455102846

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case