MEDTRONIC NAVIGATION, INC.

Address:826 COAL CREEK CIR.,LOUISVILLE,CO,80027,US

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Filters

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

Neurological stereotaxic Instrument (HAW) (10)

Premarket Exempt

No Yes

Clear

N/A - 00613994155351 Catalog Number :

Device Description : TRK KIT, 9732779, WRLESS, 12IN, PHILIPS

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

eNV® - 00613994155542 Catalog Number :

Device Description : FRAME, 9731249, HEAD TRACKER

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994155559 Catalog Number :

Device Description : ADHESIVE PAD 9732500 HEAD TRACKER 25PK

Device Class :

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 25

eNV® - 00613994155573 Catalog Number :

Device Description : TRACKER KIT, 9732781, HEAD

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994157041 Catalog Number :

Device Description : SFTWR, 9733159, TOUCH-N-GO, INSTALL

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994157089 Catalog Number :

Device Description : TRAJ GUIDE KIT, 9733067, CATHETER, ELEV

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994157096 Catalog Number :

Device Description : TRAJ GUIDE KIT, 9733066, BIOPSY, INT

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994157119 Catalog Number :

Device Description : TRAJ GUIDE KIT, 9733065, BIOPSY, EXT

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994162854 Catalog Number :

Device Description : SYSTEM KIT, 9732746, AXIEM PORTABLE, US

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994167576 Catalog Number :

Device Description : FLUORO TRACKER, 9732247, WIRELESS 12"

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

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