Catalog Number

-

Brand Name

FORA

Version/Model Number

Premium V10/V30

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K093635,K112275,K093635,K112275

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

ab863f75-bef4-4854-b486-17f95a82cfaa

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-