CLEARPOINT NEURO, INC.

Address:5 Musick,Irvine,CA,92618,US

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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) Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri (ORR) (2)

Premarket Exempt

No Yes

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Array - 00850376007604 Catalog Number : NGS-SFA-03-2

Device Description : SMARTFrame Array Kit, MR Drilling

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Array - 00850376007611 Catalog Number : CP-NGS-SFA-ORMR

Device Description : SMARTFrame Array OR-MR Procedure Kit

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Array - 00850376007628 Catalog Number : CP-NGS-SFA-MRBH

Device Description : SMARTFrame Array MR Burr Hole Procedure Kit

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Array - 00850376007635 Catalog Number : CP-NGS-SFA-MRDK

Device Description : SMARTFrame Array MR Drilling Procedure Kit

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

ClearPoint Array - 00850376007659 Catalog Number : CPA-SFW-11-11

Device Description : ClearPoint Array Software Version 1.1

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007666 Catalog Number : NGS-XG-06

Device Description : SmartFrame® XG Exchangeable Device Guide, 5.4-mm

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007703 Catalog Number : CP-SFW-11-21

Device Description : ClearPoint Software Version 2.1

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HAW, ORR

Prescription Use : Yes

Device Count : 1

SMARTFrame Array - 00850376007710 Catalog Number : NGS-SFA-DG-03

Device Description : SmartFrame® Array Offset & Center Guides, 5.4mm

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

SmartFrame - 00850376007758 Catalog Number : NGS-SF-04-11

Device Description : SMARTFrame XG MRI-Guided Trajectory Frame w/o Base

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007857 Catalog Number : CP-WRK-04

Device Description : ClearPoint Neuro v2.1 Workstation

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HAW, ORR

Prescription Use : Yes

Device Count : 1

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