Catalog Number

16483

Brand Name

NOVA

Version/Model Number

16

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K963005,K963005,K963005

Product Code

CGA

Product Code Name

GLUCOSE OXIDASE, GLUCOSE

Public Device Record Key

90ad0b2b-428f-4bf4-827c-849e7432b4fb

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2016

Package DI Number

10385480164839

Quantity per Package

2

Contains DI Package

00385480164832

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton