Catalog Number

5277298

Brand Name

LEADER

Version/Model Number

5277298

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K132086,K132086,K132086,K132086

Product Code

CGA

Product Code Name

GLUCOSE OXIDASE, GLUCOSE

Public Device Record Key

83928023-15fd-49f7-8e6e-e23025c2c4c0

Public Version Date

July 02, 2021

Public Version Number

4

DI Record Publish Date

April 24, 2017

Package DI Number

50096295129170

Quantity per Package

12

Contains DI Package

30096295129176

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE