INNERSPACE NEURO SOLUTIONS, INC.

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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

Device, Monitoring, Intracranial Pressure (GWM) (6)

Premarket Exempt

Clear

Hummingbird® - 00851680007151 Catalog Number : HICP200

Device Description : Hummingbird ICP Control Module with Patient Cable Module

Device Class : 2

Duns Number: 080333634

Premarket Exempt : No

Product Code : GWM

Prescription Use : Yes

Device Count : 1

Hummingbird® - 00851680007168 Catalog Number : H310

Device Description : H310 Hummingbird Tunneled Ventricular Catheter Kit

Device Class : 2

Duns Number: 080333634

Premarket Exempt : No

Product Code : GWM

Prescription Use : Yes

Device Count : 1

Hummingbird® - 00851680007175 Catalog Number : H110MR

Device Description : H110MR Hummingbird Parenchymal Catheter Kit

Device Class : 2

Duns Number: 080333634

Premarket Exempt : No

Product Code : GWM

Prescription Use : Yes

Device Count : 1

Hummingbird® - 00851680007182 Catalog Number : H610MR

Device Description : H610MR Hummingbird SynergyDuo Ventricular Catheter Kit

Device Class : 2

Duns Number: 080333634

Premarket Exempt : No

Product Code : GWM

Prescription Use : Yes

Device Count : 1

Hummingbird® - 00851680007199 Catalog Number : STC

Device Description : STC - Skull Thickness Caliper

Device Class : 2

Duns Number: 080333634

Premarket Exempt : No

Product Code : GWM

Prescription Use : No

Device Count : 1

Hummingbird® - 00851680007205 Catalog Number : H610

Device Description : H610 Hummingbird SynergyDuo Ventricular Catheter Kit

Device Class : 2

Duns Number: 080333634

Premarket Exempt : No

Product Code : GWM

Prescription Use : Yes

Device Count : 1

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