FDA.reportPublic FDA data

IRRAS USA, Inc

Matched from indexed company URL: IRRAS USA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30135086283013508628IRRAS USA, Inc1N2020-04-2511975 El Camino Real, Suite 304 San Diego CA US 92130

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10850013266019Hummingbird® Patient Monitor - HICP200 Hummingbird Patient / Monitor Interconnect Cable800-213-4604info@irras.com
10850013266187Hummingbird® Cranial Access Kit - IC42-D Cranial Access Kit (w/ Drugs)800-213-4604info@irras.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2066541223202670K171880IRRAflow CNS SystemJXG2018-07-13
2066541452931576K161010HICP200 Patient/Monitor Interconnect CableGWM2016-10-20
2066541089746543K113088HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)GWM2012-05-02
2066542057106437K083378SYNERGYGWM2009-09-29
2066541593785175K072379MPS OXIPORT AND MPS OXIPORT PLUSGWM2008-04-29
2066541838485001K041838MPS (OR MPS-T)GWM2005-03-01
2066541504361072K013705ACT III VENTRICULAR CATHETERGWM2002-09-09
2066541691347788K013005ACT 11 MP VENTRICULAR CATHETERHCA2002-03-08
2066541998666066K010422ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETERGWM2001-06-28
2066541171015947K003905ACTI-ICP MONITORING SYSTEMGWM2001-06-15

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GWM82016-10-20
JXG12018-07-13
HCA12002-03-08

PMN#

GUDID#