Catalog Number

64604

Brand Name

Stat Profile

Version/Model Number

Prime Plus

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

-

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

CGA

Product Code Name

GLUCOSE OXIDASE, GLUCOSE

Public Device Record Key

30221c82-50bd-4db1-ac54-43756c86148b

Public Version Date

June 14, 2022

Public Version Number

1

DI Record Publish Date

June 06, 2022

Package DI Number

10385480646045

Quantity per Package

1

Contains DI Package

00385480646048

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton