TRACKX TECHNOLOGY, LLC

Address:437 Dimmocks Road,Hillsborough,NC,27278,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Interventional Fluoroscopic X-Ray System (OWB) (6)

Premarket Exempt

Clear

TrackX - 00857088008431 Catalog Number : 604-3TX

Device Description : The device consists of a sterile Base component that mates with an Array compone The device consists of a sterile Base component that mates with an Array component to create a unique SNAP that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. The INSIGHT BASE-5L is designed to mount onto the shaft of a cylindrical instrument.

Device Class : 2

Duns Number: 080948525

Premarket Exempt : No

Product Code : OWB

Prescription Use : Yes

Device Count : 1

TrackX - 00857088008448 Catalog Number : 605-3TX

Device Description : The device consists of a sterile Base component that mates with an Array compone The device consists of a sterile Base component that mates with an Array component to create a unique SNAP that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. The INSIGHT BASE-6.5L is designed to mount onto the shaft of a cylindrical instrument.

Device Class : 2

Duns Number: 080948525

Premarket Exempt : No

Product Code : OWB

Prescription Use : Yes

Device Count : 1

TrackX - 00860099000806 Catalog Number : TX-3-3036

Device Description : Optical Tracker Snap 11 0.090 IN(previously known as Snap 1)

Device Class : 2

Duns Number: 080948525

Premarket Exempt : No

Product Code : OWB

Prescription Use : Yes

Device Count : 1

TrackX - 00860099000813 Catalog Number : TX-3-3038

Device Description : Disposable snap that snaps onto a Jamshidi for instrument tracking.Instrument Tr Disposable snap that snaps onto a Jamshidi for instrument tracking.Instrument Tracker .125 IN(previously known as Snap 2 or 12)

Device Class :

Duns Number: 080948525

Premarket Exempt : No

Product Code : OWB

Prescription Use : Yes

Device Count : 1

TrackX - 00860099000837 Catalog Number : N/A

Device Description : TrackX Software

Device Class : 2

Duns Number: 080948525

Premarket Exempt : No

Product Code : OWB

Prescription Use : Yes

Device Count : 1

TrackX - 00860099000882 Catalog Number : TX-3-3070

Device Description : Disposable snap that snaps onto a Jamshidi for instrument tracking.

Device Class : 2

Duns Number: 080948525

Premarket Exempt : No

Product Code : OWB

Prescription Use : Yes

Device Count : 1

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