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) (1) Shunt, Central Nervous System And Components (JXG) (1)

Premarket Exempt

No Yes

Clear

IRRAflow® Drainage Collection System - 00868643000470 Catalog Number : DCS 010

Device Description : DCS 010 Drainage Collection System

Device Class : 2

Duns Number: 056999617

Premarket Exempt : No

Product Code : JXG, GWM

Prescription Use : Yes

Device Count : 1

Hummingbird® Cranial Access Kit - 00868643000487 Catalog Number : IC40-D

Device Description : IC40-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 - 00868643000494 Catalog Number : IC40

Device Description : IC40 Cranial Access Kit

Device Class :

Duns Number: 056999617

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

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