Catalog Number

-

Brand Name

Fifty50

Version/Model Number

163308-302

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K083468,K083468

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

839a7f59-b4c1-432d-abf3-4aea8d6a1ab5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

10892896000083

Quantity per Package

70

Contains DI Package

00892896000086

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case Carton