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

Holder, Head, Neurosurgical (Skull Clamp) (HBL) (9) Automated Radiological Image Processing Software (QIH) (1)

Premarket Exempt

No Yes

Clear

ClearPoint Maestro - 00850359007966 Catalog Number : CPM-SFW-1

Device Description : ClearPoint Maestro Brain Model Software Version 1.0

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : QIH

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007000 Catalog Number : CP-MPHFF-132-01

Device Description : ClearPoint Multi-Positional Head Fixation Frame/Table Mounts for Siemens Sola/Vida tables

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007017 Catalog Number : CP- HFF-111-01

Device Description : ClearPoint SMS Avanto/Espree/ Symphony/Sonata Table HFF/Base

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007024 Catalog Number : CP-HFF-112-01

Device Description : ClearPoint® Siemens Avanto/Espree/ Symphony/Sonata Table HFF

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007031 Catalog Number : CP-HFF-122-01

Device Description : ClearPoint® Siemens Aera/Skyra Table Head Fixation Frame

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007048 Catalog Number : CP- HFF-211-01

Device Description : ClearPoint IMRIS T –Series Table Head Fixation Frame/Base

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007055 Catalog Number : CP-HFF-212-01

Device Description : ClearPoint® IMRIS ORT 100 Head Fixation Frame

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007062 Catalog Number : CP-HFF-222-01

Device Description : ClearPoint® IMRIS ORT 200 Head Fixation Frame

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007079 Catalog Number : CP-ITE-01

Device Description : ClearPoint IMRIS ORT 200 Table Extension

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007086 Catalog Number : CP-STB-210-01

Device Description : ClearPoint IMRIS Table Stabilizer

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

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