Catalog Number

G8-203S50

Brand Name

Easygluco® Plus Test Strips

Version/Model Number

IGM-0035

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

K110435,K110435

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

72c5ba1a-c198-4ee0-bcb7-a5167760bfa7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 13, 2017

Package DI Number

00885502002192

Quantity per Package

2

Contains DI Package

10885502002199

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-