IRRAS USA

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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) (8) Shunt, Central Nervous System And Components (JXG) (4)

Premarket Exempt

No Yes

Clear

Hummingbird® Patient Monitor - 00850013266012 Catalog Number : HICP200

Device Description : HICP200 Hummingbird Patient / Monitor Interconnect Cable

Device Class : 2

Duns Number: 056999617

Premarket Exempt : No

Product Code : GWM

Prescription Use : Yes

Device Count : 1

Hummingbird® SynergyDuo - 00850013266029 Catalog Number : H610

Device Description : H610 Hummingbird SynergyDuo Ventricular Catheter Tray

Device Class : 2

Duns Number: 056999617

Premarket Exempt : No

Product Code : GWM

Prescription Use : Yes

Device Count : 1

Hummingbird® Parenchymal Catheter - 00850013266036 Catalog Number : H110

Device Description : H110 Hummingbird Parenchymal Catheter Tray

Device Class : 2

Duns Number: 056999617

Premarket Exempt : No

Product Code : GWM

Prescription Use : Yes

Device Count : 1

Hummingbird® HICP200 Monitor Interconnect Cable - Spacelabs 6 Pin Monitor - 00850013266104 Catalog Number : 7000332

Device Description : Hummingbird® HICP200 Monitor Interconnect Cable - Spacelabs 6 Pin Monitor

Device Class : 2

Duns Number: 056999617

Premarket Exempt : Yes

Product Code : GWM

Prescription Use : Yes

Device Count : 1

Hummingbird® Cranial Access Kit - 00850013266180 Catalog Number : IC42-D

Device Description : IC42-D Cranial Access Kit (w/ Drugs)

Device Class :

Duns Number: 056999617

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

Hummingbird® Cranial Access Kit - 00850013266197 Catalog Number : IC42

Device Description : IC42 Cranial Access Kit

Device Class :

Duns Number: 056999617

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

IRRAflow® - 00868643000401 Catalog Number : ICCU 020

Device Class : 2

Duns Number: 056999617

Premarket Exempt : No

Product Code : GWM, JXG

Prescription Use : Yes

Device Count : 1

IRRAflow® Cassette and Tube Set - 00868643000418 Catalog Number : ICDS 020

Device Class :

Duns Number: 056999617

Premarket Exempt : No

Product Code : GWM, JXG

Prescription Use : Yes

Device Count : 1

IRRAflow® 1.5 Catheter - 00868643000425 Catalog Number : ICGS 010

Device Class :

Duns Number: 056999617

Premarket Exempt : No

Product Code : GWM, JXG

Prescription Use : Yes

Device Count : 1

IRRAflow® 2.0 Catheter - 00868643000432 Catalog Number : ICGS 020

Device Class :

Duns Number: 056999617

Premarket Exempt : No

Product Code : GWM, JXG

Prescription Use : Yes

Device Count : 1

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