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 (HAW) (6) Drape, Surgical (KKX) (3) Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri (ORR) (1)

Premarket Exempt

No Yes

Clear

ClearPoint - 00850359007201 Catalog Number : NGS-PD-03-L

Device Description : MR Neuro Drape Tapered w/Extension (GE)-Long

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : KKX

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850359007218 Catalog Number : NGS-PD-04

Device Description : MR Scanner Bore Drape w/Extension (IMRIS)

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : KKX

Prescription Use : Yes

Device Count : 1

ClearPoint - 00850359007225 Catalog Number : NGS-PD-05

Device Description : MR Neuro Patient Drape (IMRIS)

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : KKX

Prescription Use : Yes

Device Count : 1

SmartFrame - 00850359007232 Catalog Number : NGS-GT-01

Device Description : SMARTFrame Guide Tubes

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

SmartFrame - 00850359007249 Catalog Number : NGS-GT-02

Device Description : SMARTFrame Guide Tubes .052” / 18 ga

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

SmartFrame - 00850359007256 Catalog Number : NGS-GT-03

Device Description : SMARTFrame Guide Tubes .060” / 17 ga

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

SmartFrame - 00850359007263 Catalog Number : NGS-GT-04

Device Description : SMARTFrame Guide Tubes .064” / CP Stylet

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

SmartFrame - 00850359007270 Catalog Number : NGS-GT-05

Device Description : SMARTFrame Guide Tubes .068” / 16 ga

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

SmartFrame - 00850359007287 Catalog Number : NGS-GT-06

Device Description : SMARTFrame Guide Tubes .074” / 15 ga

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

MRII - 00850359007294 Catalog Number : NGS-EC-16X24-06

Device Description : Flexible Self Adhesive Equipment Cover,16 x 24, 6 mil

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : ORR

Prescription Use : Yes

Device Count : 1

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