Catalog Number

64230

Brand Name

TruePoint

Version/Model Number

64230

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

-

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

a8cad95f-383f-473f-b922-52a787f7a43a

Public Version Date

October 29, 2018

Public Version Number

1

DI Record Publish Date

September 28, 2018

Package DI Number

10193169642307

Quantity per Package

24

Contains DI Package

00193169642300

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case