Catalog Number

-

Brand Name

DUODERM

Version/Model Number

187970

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

a6945dd3-c207-4cb7-8308-eb8627052c3a

Public Version Date

October 18, 2022

Public Version Number

5

DI Record Publish Date

April 12, 2019

Package DI Number

10768455102836

Quantity per Package

30

Contains DI Package

00768455102839

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case