Catalog Number

100-50

Brand Name

GenUltimate!

Version/Model Number

100-50

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

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

9368f0cd-a038-444b-9305-a96944a294d6

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 01, 2016

Package DI Number

10868906000121

Quantity per Package

18

Contains DI Package

10868906000107

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case