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 - 00613994123589 Catalog Number :

Device Description : FRAME 9732159 QUICK RELEASE 1

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994123596 Catalog Number :

Device Description : FRAME 9732160 QUICK RELEASE 2

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994128195 Catalog Number :

Device Description : PROBE, 9732374, ENV OSTIUM SEEKER

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994129024 Catalog Number :

Device Description : FLUORO TRACKER 9732222 WIRELESS 9 INCH

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994131232 Catalog Number :

Device Description : TRK KIT, 9732780, WRLESS, 9 IN, SIEMENS

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994131249 Catalog Number :

Device Description : TRK KIT, 9732778, WRLESS, 9 IN, PHILIPS

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994131256 Catalog Number :

Device Description : RK KIT 9732776 WRLESS 9 IN 96-9800

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994131263 Catalog Number :

Device Description : TRK KIT, 9732829, WRLESS, 9 IN NAVLNK

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994131416 Catalog Number :

Device Description : HW INTERFACE 9733048 ISOC3D/ORBIC

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : No

Device Count : 1

N/A - 00613994131706 Catalog Number :

Device Description : SYSTEM 9660651R AXIEM PORTABLE REFURBA^

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

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