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) (10)

Premarket Exempt

Yes

Clear

Compass International - B169REG30020 Catalog Number : REG-3002

Device Description : Radiographic Markers - Large Disc

Device Class : 2

Duns Number: 809466410

Premarket Exempt : Yes

Product Code : HAW

Prescription Use : No

Device Count : 1

Compass International - B169REG30BC0 Catalog Number : REG-30-BC

Device Description : Regulus Suction TIp - Center

Device Class : 2

Duns Number: 809466410

Premarket Exempt : Yes

Product Code : HAW

Prescription Use : No

Device Count : 1

Compass International - B169REG30BCENT0 Catalog Number : REG-30-BCENT

Device Description : Regulus Long Suction (ENT)

Device Class : 2

Duns Number: 809466410

Premarket Exempt : Yes

Product Code : HAW

Prescription Use : No

Device Count : 1

Compass International - B169REG30D0 Catalog Number : REG-30-D

Device Description : Regulus Pointer Tip

Device Class : 2

Duns Number: 809466410

Premarket Exempt : Yes

Product Code : HAW

Prescription Use : No

Device Count : 1

Compass International - B169REGBCBAY0 Catalog Number : REG-BCBAY

Device Description : Regulus Bayonette Tip (30 degree)

Device Class : 2

Duns Number: 809466410

Premarket Exempt : Yes

Product Code : HAW

Prescription Use : No

Device Count : 1

Compass International - B169RFS100 Catalog Number : RFS-10

Device Description : Remote Foot Switch

Device Class : 2

Duns Number: 809466410

Premarket Exempt : Yes

Product Code : HAW

Prescription Use : No

Device Count : 1

Compass International - B169RU1500 Catalog Number : RU-150

Device Description : 150 MM Ruler

Device Class : 2

Duns Number: 809466410

Premarket Exempt : Yes

Product Code : HAW

Prescription Use : No

Device Count : 1

Compass International - B169RU3000 Catalog Number : RU-300

Device Description : 300 MM Ruler

Device Class : 2

Duns Number: 809466410

Premarket Exempt : Yes

Product Code : HAW

Prescription Use : No

Device Count : 1

Compass International - B169SLS100 Catalog Number : SLS-10

Device Description : Slide Locking Screw

Device Class : 2

Duns Number: 809466410

Premarket Exempt : Yes

Product Code : HAW

Prescription Use : No

Device Count : 1

Compass International - B169SOFTWARE0 Catalog Number : SOFTWARE

Device Description : Software Maintenance Contract

Device Class : 2

Duns Number: 809466410

Premarket Exempt : Yes

Product Code : HAW

Prescription Use : No

Device Count : 1

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