Catalog Number

-

Brand Name

AgaMatrix

Version/Model Number

8000-10473

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

-

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

2d727783-488b-4ad7-8345-00111f72be9a

Public Version Date

December 03, 2018

Public Version Number

4

DI Record Publish Date

July 11, 2016

Package DI Number

10385541002407

Quantity per Package

12

Contains DI Package

00385541002301

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper