Catalog Number

TX-3-3108

Brand Name

TrackX

Version/Model Number

VISION-T SNAP

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K173736,K173736,K173736

Product Code

OWB

Product Code Name

Interventional Fluoroscopic X-Ray System

Public Device Record Key

54d8203b-5a85-4a88-9f39-79f8ac48d744

Public Version Date

November 09, 2018

Public Version Number

1

DI Record Publish Date

October 09, 2018

Package DI Number

00857088008066

Quantity per Package

5

Contains DI Package

00857088008042

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Carton