MEDTRONIC NAVIGATION, INC.

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

StealthStation Treon AxiEM - 00613994097262 Catalog Number :

Device Description : AXIEM KIT 9732661 PORTABLE 110

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994098511 Catalog Number :

Device Description : PLATE, 9732269, INSTRUMENT VERIFICATION

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994099488 Catalog Number :

Device Description : SOFTWARE 9732811 MICROCAL PLUS

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994100467 Catalog Number :

Device Description : TRAY 9732634XOM ENV INSTR STERILIZATION

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

StealthStation® AXIEM™ System - 00613994109477 Catalog Number :

Device Description : AXIEM KIT, 9732750, PORTABLE PRE-BUILD

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994110831 Catalog Number :

Device Description : WRKSTN, 9732585, STLTHSTN INAV II

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994110909 Catalog Number :

Device Description : TRAY 9732630 STERILIZATION, KNEE

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994114457 Catalog Number :

Device Description : WORKSTATION 9732050 STIMPILOT 50902B

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994120410 Catalog Number :

Device Description : INSTR 9732622 UNIV ITKR WIRELESS

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 00613994123565 Catalog Number :

Device Description : BASE 9732520 QUICK RELEASE

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

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