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) Neurological Stereotaxic Instrument (HAW) (1)

Premarket Exempt

No Yes

Clear

ClearPoint - 00850376007499 Catalog Number : CP-INHFF-122-01

Device Description : ClearPoint Inflexion Head Fixation Frame/Table Mount for Siemens Aera/Skyra scanners

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

ClearPoint Inflexion IMRIS Head Fixation Frame - 00850376007505 Catalog Number : CP-INHFF-232-01

Device Description : Inflexion Head Fixation Frame fits IMRIS surgical tables

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007512 Catalog Number : CP-INHFF-132-01

Device Description : ClearPoint Inflexion Head Fixtation Frame/Table Mount for Siemens Sola/Vida tables.

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007536 Catalog Number : CP-INHFF-322-01

Device Description : ClearPoint Inflexion Head Fixation Frame/Table Mount for GE HDw/450w scanner tables

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007543 Catalog Number : CP-INHFF-332-01

Device Description : ClearPoint Inflexion Head Fixation Frame/Table Mount for GE750w Scanners

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007550 Catalog Number : CP-INHFF-412-01

Device Description : ClearPoint Inflexion Head Fixation Frame/Table Mount for Philips Achieva scanner tables

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007567 Catalog Number : CP-INHFF-422-01

Device Description : ClearPoint Inflexion Head Fixation Frame/Table Mount for Philips Ingenia scanner tables

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007574 Catalog Number : CP-INHFF-342-01

Device Description : ClearPoint Head Fixation Frame/Table Mounts for GE Premier tables.

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850376007581 Catalog Number : CP-INHFF-242-01

Device Description : ClearPoint Inflexion Head Fixation Frame/Table Mount for IMRIS Aera-Skyra tables.

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HBL

Prescription Use : Yes

Device Count : 1

SmartFrame Array - 00850376007598 Catalog Number : NGS-SFA-02-2

Device Description : Array Kit with navigation frame, used mainly for burr hole procedures

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

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