Compass International

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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) (6)

Premarket Exempt

Yes

Clear

Compass International - B169SP200 Catalog Number : SP-20

Device Description : Sharp Pins (titanium) w/collets

Device Class : 2

Duns Number: 809466410

Premarket Exempt : Yes

Product Code : HAW

Prescription Use : No

Device Count : 1

Compass International - B169SS100 Catalog Number : SS-10

Device Description : Storage Stand

Device Class : 2

Duns Number: 809466410

Premarket Exempt : Yes

Product Code : HAW

Prescription Use : No

Device Count : 1

Compass International - B169SST100 Catalog Number : SST-10

Device Description : Sundt Stereotaxic Suction Tip

Device Class : 2

Duns Number: 809466410

Premarket Exempt : Yes

Product Code : HAW

Prescription Use : No

Device Count : 1

Compass International - B169TP100 Catalog Number : TP-10

Device Description : Chambered Test Phantom (Frame)

Device Class : 2

Duns Number: 809466410

Premarket Exempt : Yes

Product Code : HAW

Prescription Use : No

Device Count : 1

Compass International - B169TP300 Catalog Number : TP-30

Device Description : Cygnus Test Phantom

Device Class : 2

Duns Number: 809466410

Premarket Exempt : Yes

Product Code : HAW

Prescription Use : No

Device Count : 1

Compass International - B169VS300 Catalog Number : VS-30

Device Description : Vertical Support with Base Fixation

Device Class : 2

Duns Number: 809466410

Premarket Exempt : Yes

Product Code : HAW

Prescription Use : No

Device Count : 1

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