Catalog Number

MNG425U

Brand Name

NU-GEL®

Version/Model Number

MNG425U

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)

Yes

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

26d402cb-b85d-47c6-904c-0b08ee3f61a9

Public Version Date

September 09, 2020

Public Version Number

3

DI Record Publish Date

September 24, 2019

Package DI Number

25051978010019

Quantity per Package

6

Contains DI Package

15051978010012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-