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, Real-Time Intraoperative Mri (ORR) (2) Neurological Stereotaxic Instrument (HAW) (1)

Premarket Exempt

No Yes

Clear

ClearPoint - 00850359007003 Catalog Number : CP-SFW-11-203

Device Description : ClearPoint Software Version 2.0.3

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : ORR, HAW

Prescription Use : Yes

Device Count : 1

SmartFrame - 00850359007010 Catalog Number : CP-NGS-11-HC

Device Description : SMARTFrame Kit w/ HC

Device Class :

Duns Number: 959181160

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

SmartFrame - 00850359007027 Catalog Number : CP-NGS-11-TE

Device Description : SMARTFrame Kit w/ TE

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : ORR

Prescription Use : Yes

Device Count : 1

SmartFrame - 00850359007034 Catalog Number : CP-NGS-11-HC-SCM

Device Description : SMARTFrame Scalp Mount Kit w/ HC

Device Class :

Duns Number: 959181160

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

SmartFrame - 00850359007041 Catalog Number : CP-NGS-11-TE-SCM

Device Description : SMARTFrame Scalp Mount Kit w/ TE

Device Class :

Duns Number: 959181160

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

SmartFrame - 00850359007058 Catalog Number : CP-NGS-11-HC-TP32

Device Description : SMARTFrame XG TwistPoint Kit w/ HC

Device Class :

Duns Number: 959181160

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

SmartFrarme - 00850359007065 Catalog Number : CP-NGS-11-TE-TP32

Device Description : SMARTFrame XG TwistPoint Kit w/ TE

Device Class :

Duns Number: 959181160

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

SmartFrame - 00850359007072 Catalog Number : CP-NGS-11-HC-TP32-E

Device Description : SMARTFrame XG TwistPoint Kit w/ HC - E

Device Class :

Duns Number: 959181160

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

SmartFrame - 00850359007089 Catalog Number : CP-NGS-11-HC-TP45

Device Description : SMARTFrame XG 4.5 TwistPoint Kit w/ HC

Device Class :

Duns Number: 959181160

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

SmartFrame - 00850359007096 Catalog Number : CP-NGS-11-TE-TP45

Device Description : SMARTFrame XG 4.5 TwistPoint Kit w/ TE

Device Class :

Duns Number: 959181160

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

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