Catalog Number

99GS300115

Brand Name

Rightest

Version/Model Number

GS300

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

K062567,K062567,K062567,K062567,K062567

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

e521e505-080f-4d32-9fcf-a1c867cc7611

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 06, 2017

Package DI Number

20883489001034

Quantity per Package

12

Contains DI Package

10883489001037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton