Catalog Number

-

Brand Name

DUODERM PASTE AND GELS

Version/Model Number

187990

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NAE

Product Code Name

Dressing, Wound, Hydrogel Without Drug And/Or Biologic

Public Device Record Key

7a5c5ad7-1b9d-400d-8893-6bef6a6d085f

Public Version Date

October 11, 2022

Public Version Number

2

DI Record Publish Date

September 05, 2022

Package DI Number

00768455108640

Quantity per Package

10

Contains DI Package

00768455172993

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton