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

Holder, Head, Neurosurgical (Skull Clamp) (HBL) (10)

Premarket Exempt

No Yes

Clear

ClearPoint - 00850376007192 Catalog Number : CP-AHF-312-01

Device Description : ClearPoint Adjustable Table Mount, GE HDx-Integra

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007208 Catalog Number : CP-AHF-322-01

Device Description : ClearPoint Adjustable Table Mount, GE 450w (HDw)-Integra

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007215 Catalog Number : CP-AHF-332-01

Device Description : ClearPoint Adjustable Table Mount, GE 750w-Integra

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007222 Catalog Number : CP-AHF-411-01

Device Description : ClearPoint Adjustable Table Mount, Philips Achieva -DORO

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007239 Catalog Number : CP-AHF-421-01

Device Description : ClearPoint Adjustable Table Mount, Philips Ingenia - DORO

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007246 Catalog Number : CP-MPHFF-112-01

Device Description : ClearPoint Multi-Positional HFF/Table Mounts for Siemens Avanto/Espree/Symphony/Sonata

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007253 Catalog Number : CP-MPHFF-122-01

Device Description : ClearPoint Multi-Positional HF/Table Mounts for Siemens Aera/Skyra

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007260 Catalog Number : CP-MPHFF-211-01

Device Description : ClearPoint Multi-Positional HFF/Table Mounts for IMRIS with Base

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007277 Catalog Number : CP-MPHFF-212-01

Device Description : ClearPoint Multi-Positional HF/Table Mounts for IMRIS with ORT 100 Table

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007284 Catalog Number : CP-MPHFF-222-01

Device Description : ClearPoint Multi-Positional HF/Table Mounts for IMRIS with ORT 200 Table

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

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