TrackX - The device consists of a sterile Snap that - TRACKX TECHNOLOGY, LLC

Duns Number:080948525

Device Description: The device consists of a sterile Snap that includes reflective features that facilitate im The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system.

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More Product Details

Catalog Number

TX-3-3109

Brand Name

TrackX

Version/Model Number

VISION™-V SNAP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

Product Code Details

Product Code

OWB

Product Code Name

Interventional Fluoroscopic X-Ray System

Device Record Status

Public Device Record Key

879f1d94-e38e-419f-9013-b8dde11892f5

Public Version Date

December 12, 2019

Public Version Number

1

DI Record Publish Date

December 04, 2019

Additional Identifiers

Package DI Number

00857088008097

Quantity per Package

5

Contains DI Package

00857088008080

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"TRACKX TECHNOLOGY, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 33