Catalog Number

TX-3-3148

Brand Name

TrackX

Version/Model Number

12 inch Source Cap Original Assembly

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K173736

Product Code

OWB

Product Code Name

Interventional Fluoroscopic X-Ray System

Public Device Record Key

d5abe1da-e5c5-4da4-a0a9-d8e80ec93416

Public Version Date

October 01, 2018

Public Version Number

1

DI Record Publish Date

August 29, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-