CLEARPOINT NEURO, INC.

Address:5 Musick,Irvine,CA,92618,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) (7) Drills, Burrs, Trephines & Accessories (Manual) (HBG) (3)

Premarket Exempt

No Yes

Clear

SmartFrame - 00850359007300 Catalog Number : NGS-XG-01

Device Description : SMARTFrame XG Exchangeable Device Guides

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

SmartFrame - 00850359007317 Catalog Number : NGS-XG-02

Device Description : SmartFrame® XG Exchangeable Device Guide, 4.5-mm

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

SmartFrame - 00850359007324 Catalog Number : NGS-SM-01

Device Description : SMARTFrame Scalp Mount Base

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

SmartFrame - 00850359007331 Catalog Number : NGS-SK-01-11

Device Description : SmartFrame® Skull Mount Base

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

SmartTwist - 00850359007348 Catalog Number : NGS-HD-01

Device Description : SmartTwist MRII Hand Drill

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBG

Prescription Use : Yes

Device Count : 1

SmartTip - 00850359007355 Catalog Number : NGS-DB-01

Device Description : SmartTip MRII Drill Kit, 3.2-mm

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBG

Prescription Use : Yes

Device Count : 1

SmartTip - 00850359007362 Catalog Number : NGS-DB-45

Device Description : SmartTip MRII Drill Kit, 4.5 mm

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBG

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850359007379 Catalog Number : NGS-BM-05

Device Description : ClearPoint MRI Fiducial Markers

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

SmartFrame - 00850359007386 Catalog Number : NGS-CG-01

Device Description : SMARTFrame Wharen Centering Guide

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

SmartFrame - 00850359007393 Catalog Number : NGS-RS-01

Device Description : SMARTFrame Skull Mount Rescue Screw

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

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