Catalog Number

200-4TX

Brand Name

TrackX

Version/Model Number

ACUITY NEEDLE - DIAMOND; 200-4TX

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

4267670b-cc9e-4803-8388-a087f7df10f2

Public Version Date

October 04, 2022

Public Version Number

1

DI Record Publish Date

September 26, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-