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

StimPilot™ -DBS™ Solution Software - 00885074217864 Catalog Number :

Device Description : SFTWR 9732112 INSTALLATION STIMPILOT

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : No

Device Count : 1

DBS™ Solution- StimPilot™ Software - 00885074221359 Catalog Number :

Device Description : SFTWR 9732113 LICENSE/ARCHIVE STIMPILOT

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

StimPilot™ Application - 00885074221595 Catalog Number :

Device Description : SFTWR 9732111 APPLICATION STIMPILOT

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : No

Device Count : 1

N/A - 00885074227337 Catalog Number :

Device Description : TRAY, 9731808 STERILIZATION

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

AXIEM™ - 00885074238227 Catalog Number :

Device Description : SHUNT PACK 9731976 AXIEM SKULL MOUNTED

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

AXIEM™ - 00885074238241 Catalog Number :

Device Description : PACK 9731975 TUMOR RESECTION AXIEM CR

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00885074240091 Catalog Number :

Device Description : FIELD GENERATOR 9731203 EM MOBILE

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00885074240114 Catalog Number :

Device Description : HOLDER 9731450 MOBILE LOCALIZER

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00885074240121 Catalog Number :

Device Description : DRIVER 9731833 1/4" BALL HEX

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00885074262086 Catalog Number :

Device Description : TRAY, 9731968, ORTHONAV STERILIZATION

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : No

Device Count : 1

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