Catalog Number

-

Brand Name

Trak

Version/Model Number

TTK-0-1 Rev 2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 22, 2021

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

POV

Product Code Name

Semen Analysis Device

Public Device Record Key

b65d8a75-ae58-4319-8017-2a6d7641816c

Public Version Date

May 17, 2022

Public Version Number

4

DI Record Publish Date

June 23, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-