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

Cannula, Ventricular (HCD) (8) Neurological Stereotaxic Instrument (HAW) (2)

Premarket Exempt

No Yes

Clear

SmartFrame - 00850359007409 Catalog Number : NGS-RS-02

Device Description : SMARTFrame Scalp Mount Rescue Screw - Long

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

SmartFrame - 00850359007416 Catalog Number : NGS-RS-03

Device Description : SMARTFrame Scalp Mount Rescue Screw- Short

Device Class : 2

Duns Number: 959181160

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

SmartFlow - 00850359007423 Catalog Number : NGS-NC-01

Device Description : Smart Flow Neuro Ventricular Cannula, 16 ga, .008” ID x 4 ft x 18mm tip

Device Class : 1

Duns Number: 959181160

Premarket Exempt : No

Product Code : HCD

Prescription Use : Yes

Device Count : 1

SmartFlow - 00850359007430 Catalog Number : NGS-NC-02

Device Description : Smart Flow Neuro Ventricular Cannula, 16 ga, .008” ID x 10 ft x 18mm tip

Device Class : 1

Duns Number: 959181160

Premarket Exempt : No

Product Code : HCD

Prescription Use : Yes

Device Count : 1

SmartFlow - 00850359007447 Catalog Number : NGS-NC-03

Device Description : Smart Flow Neuro Ventricular Cannula, 14 ga, .021” ID x 4 ft x 18mm tip

Device Class : 1

Duns Number: 959181160

Premarket Exempt : No

Product Code : HCD

Prescription Use : Yes

Device Count : 1

SmartFlow - 00850359007454 Catalog Number : NGS-NC-04

Device Description : Smart Flow Neuro Ventricular Cannula, 14 ga, .021” ID x 10 ft x 18mm tip

Device Class : 1

Duns Number: 959181160

Premarket Exempt : No

Product Code : HCD

Prescription Use : Yes

Device Count : 1

SmartFlow - 00850359007461 Catalog Number : NGS-NC-05

Device Description : Smart Flow Neuro Ventricular Cannula, 16ga, .008 ID x 10 ft x 15mm tip

Device Class : 1

Duns Number: 959181160

Premarket Exempt : No

Product Code : HCD

Prescription Use : Yes

Device Count : 1

SmartFlow - 00850359007478 Catalog Number : NGS-NC-06

Device Description : Smart Flow Neuro Ventricular Cannula, 16ga, .008 ID x 10 ft x 13mm tip

Device Class : 1

Duns Number: 959181160

Premarket Exempt : No

Product Code : HCD

Prescription Use : Yes

Device Count : 1

Smartflow - 00850359007485 Catalog Number : NGS-NC-07

Device Description : Smart Flow Neuro Ventricular Cannula, 14ga, .021 ID x 10 ft x 13mm tip

Device Class : 1

Duns Number: 959181160

Premarket Exempt : No

Product Code : HCD

Prescription Use : Yes

Device Count : 1

SmartFlow - 00850359007492 Catalog Number : NGS-NC-08

Device Description : Smart Flow Neuro Ventricular Cannula, 14ga, .021 ID x 10 ft x 13mm tip (short)

Device Class : 1

Duns Number: 959181160

Premarket Exempt : No

Product Code : HCD

Prescription Use : Yes

Device Count : 1

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