Catalog Number

8H219UL

Brand Name

MicroTrak®

Version/Model Number

8H219UL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2019

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

-

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

GON

Product Code Name

Antigen, Cf (Including Cf Control), Rubella

Public Device Record Key

025e071d-4143-4219-9369-da24143f770a

Public Version Date

May 10, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-