Address:437 Dimmocks Road,Hillsborough,NC,27278,US
Device Description : The device consists of a sterile Screw Length Calibrator that includes reflectiv The device consists of a sterile Screw Length Calibrator that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. The Screw Length Calibrator is utilized with the TrackX VISION™-V SNAP.
Device Class : 2
Duns Number: 080948525
Premarket Exempt : No
Prescription Use : Yes
Device Description : The device consists of a sterile Calibrator that includes reflective features th The device consists of a sterile Calibrator that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system.
Device Class : 2
Duns Number: 080948525
Premarket Exempt : No
Prescription Use : Yes
Device Description : The device is a general surgical instrument: a non-sterile, reusable Pointer instrument.
Device Class : 2
Duns Number: 080948525
Premarket Exempt : No
Prescription Use : Yes
Device Description : The device consists of a sterile Snap that includes reflective features that fac 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.
Device Class : 2
Duns Number: 080948525
Premarket Exempt : No
Prescription Use : Yes
Device Description : The device consists of a sterile Snap that includes reflective features that fac 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. The INSIGHT™-6 SNAP Kit is designed to mount onto the shaft of a cylindrical instrument.
Device Class : 2
Duns Number: 080948525
Premarket Exempt : No
Prescription Use : Yes
Device Description : The device is a general surgical instrument: a sterilized, disposable, single us The device is a general surgical instrument: a sterilized, disposable, single use jamshidi like needle.
Device Class : 2
Duns Number: 080948525
Premarket Exempt : No
Prescription Use : Yes
Device Description : The device consists of a sterile Array component that mates with an INSIGHT Base The device consists of a sterile Array component that mates with an INSIGHT Base 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™ ARRAY-ORANGE when assembled with an INSIGHT Base is designed to mount onto the shaft of a cylindrical instrument.
Device Class : 2
Duns Number: 080948525
Premarket Exempt : No
Prescription Use : Yes
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 is designed to mount onto the shaft of a cylindrical instrument.
Device Class : 2
Duns Number: 080948525
Premarket Exempt : No
Prescription Use : Yes
Device Description : The device consists of a sterile Snap that includes reflective features that fac 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.
Device Class : 2
Duns Number: 080948525
Premarket Exempt : No
Prescription Use : Yes
Device Description : The device consists of a sterile Calibrator that includes reflective features th The device consists of a sterile Calibrator that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system.
Device Class : 2
Duns Number: 080948525
Premarket Exempt : No
Prescription Use : Yes