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) (4) Drape, surgical (KKX) (1) Image-intensified fluoroscopic x-ray system, mobile (OXO) (1)

Premarket Exempt

No Yes

Clear

N/A - 20763000547107 Catalog Number :

Device Description : SILICONE PAD 9732501XOM 3PK ENT

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 3

N/A - 20885074445841 Catalog Number :

Device Description : ADHESIVE PAD 9732500XOM 25PK ENT

Device Class : 2

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

N/A - 20885074445858 Catalog Number :

Device Description : SILICONE PAD 9732501XOM 3PK ENT

Device Class :

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 3

O-ARM® - 20885074546180 Catalog Number :

Device Description : MOUSE 9732721 STERILE O-ARM 10PK

Device Class :

Duns Number: 803580559

Premarket Exempt : No

Product Code : OXO

Prescription Use : Yes

Device Count : 10

O-ARM® - 20885074546203 Catalog Number :

Device Description : DRAPE 9732722 TUBE STERILE O-ARM 20PK

Device Class :

Duns Number: 803580559

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : Yes

Device Count : 20

N/A - 70613994155565 Catalog Number :

Device Description : SILICONE PAD 9732501 HEAD TRACKER 3PK

Device Class :

Duns Number: 835233107

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

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