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) (8) Needle, Aspiration And Injection, Disposable (GAA) (2)

Premarket Exempt

Yes

Clear

Compass International - B169CYG4FCT100 Catalog Number : CYG-4F-CT10

Device Description : Cygnus-PFS 4F Catheter Tracker

Device Class : 2

Duns Number: 809466410

Premarket Exempt : Yes

Product Code : HAW

Prescription Use : No

Device Count : 1

Compass International - B169CYG4FCT10TP0 Catalog Number : CYG-4F-CT10TP

Device Description : TracPlus 4F Catheter Tracker

Device Class : 2

Duns Number: 809466410

Premarket Exempt : Yes

Product Code : HAW

Prescription Use : No

Device Count : 1

Compass International - B169CYG5FNPT100 Catalog Number : CYG-5F-NPT10

Device Description : Cygnus-PFS 5F Needle Point Tracker

Device Class : 2

Duns Number: 809466410

Premarket Exempt : Yes

Product Code : HAW

Prescription Use : No

Device Count : 1

Compass International - B169CYG5FNPT10TP0 Catalog Number : CYG-5F-NPT10TP

Device Description : TracPlus 5F Needle Pointer Tracker

Device Class : 2

Duns Number: 809466410

Premarket Exempt : Yes

Product Code : HAW

Prescription Use : No

Device Count : 1

Compass International - B169CYG9FSCT100 Catalog Number : CYG-9F-SCT10

Device Description : Cygnus-PFS 9F Slit Catheter Tracker

Device Class : 2

Duns Number: 809466410

Premarket Exempt : Yes

Product Code : HAW

Prescription Use : No

Device Count : 1

Compass International - B169CYG9FSCT10TP0 Catalog Number : CYG-9F-SCT10TP

Device Description : Cygnus-PFS TracPlus 9F Slit Catheter Tracker

Device Class : 2

Duns Number: 809466410

Premarket Exempt : Yes

Product Code : HAW

Prescription Use : No

Device Count : 1

Compass International - B169CYGERG10D0 Catalog Number : CYG-ERG-10D

Device Description : Ergotron Transmitter Mount

Device Class : 2

Duns Number: 809466410

Premarket Exempt : Yes

Product Code : HAW

Prescription Use : No

Device Count : 1

Compass International - B169CYGSAP102A0 Catalog Number : CYG-SAP-10-2A

Device Description : Cygnus-PFS Surgical Arm w/Detachable End

Device Class : 2

Duns Number: 809466410

Premarket Exempt : Yes

Product Code : HAW

Prescription Use : No

Device Count : 1

Compass International - B169DBN30100 Catalog Number : DBN-30-10

Device Description : Disposable Biopsy Needle Removable Depth Stop

Device Class : 1

Duns Number: 809466410

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : No

Device Count : 1

Compass International - B169DBNP1010TP0 Catalog Number : DBNP-10-10TP

Device Description : Cygnus-PFS TracPlus Disposable Biopsy Needle

Device Class : 1

Duns Number: 809466410

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : No

Device Count : 1

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