Catalog Number

-

Brand Name

AgaMatrix

Version/Model Number

8000-03390

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

f2d45821-7fe8-452e-a6a3-07407b9878fc

Public Version Date

December 03, 2018

Public Version Number

4

DI Record Publish Date

November 04, 2016

Package DI Number

30385541001602

Quantity per Package

20

Contains DI Package

20385541001605

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Shipper