Catalog Number

TX-3-3036

Brand Name

TrackX

Version/Model Number

Snap 11

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 18, 2022

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

Product Code

OWB

Product Code Name

Interventional Fluoroscopic X-Ray System

Public Device Record Key

c155df39-bcd3-4cba-91a4-9f58d27812f4

Public Version Date

February 21, 2022

Public Version Number

3

DI Record Publish Date

April 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-