Catalog Number

GEN-BUN R1

Brand Name

GENCHEM™ UREA

Version/Model Number

GEN-BUN R1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 19, 2020

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

CDQ

Product Code Name

UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN

Public Device Record Key

8c3ea785-ea31-4ae8-ae97-15fb1c7c2ede

Public Version Date

October 21, 2022

Public Version Number

5

DI Record Publish Date

September 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-