Catalog Number

-

Brand Name

Greater Goods

Version/Model Number

0030

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

K120351,K120351

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

f21079bc-91fb-4798-a835-242fe1491ad3

Public Version Date

July 19, 2021

Public Version Number

1

DI Record Publish Date

July 11, 2021

Package DI Number

10875011000304

Quantity per Package

1

Contains DI Package

00875011000307

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master carton