DIROS TECHNOLOGY, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80433983003630373DIROS TECHNOLOGY, INC.1N2026-01-01120 GIBSON DRIVE MARKHAM Ontario CA L3R 2Z3

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
00825114000032OWL - OWL RadioFrequency RF Lesion Generator905-415-3440RBAKER@DIROSTECH.COM
00825114001664OWL - OWL STERILE SINGLE USE DISPOSABLE GASSERIAN GANGLION RF INSULATED CANNULA (19GA), 105MM LONG, 5MM BARE TIP9054153440RBAKER@DIROSTECH.COM
00825114001732OWL - OWL STERILE SINGLE USE DISPOSABLE FACET DENERVATION R.F. PROBE/TEMPERATURE SENSOR FOR 5 CM CANNULA (THERMOCOUPLE)9054153440RBAKER@DIROSTECH.COM
00825114001862OWL - OWL STERILE SINGLE USE DISPOSABLE RF INSULATED CANNULA (22 Ga.), 54 mm LONG, 4 mm BARE TIP9054153440RBAKER@DIROSTECH.COM
00825114001879OWL - OWL STERILE SINGLE USE DISPOSABLE BLUNT CURVED RF INSULATED CANNULA (22 Ga.), 54mm LONG, 5MM BARE TIP9054153440RBAKER@DIROSTECH.COM
00825114001886OWL - OWL STERILE SINGLE USE DISPOSABLE RF INSULATED CANNULA (22 Ga.), 100 mm LONG, 5 mm BARE TIP9054153440RBAKER@DIROSTECH.COM

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
429061952728973K170708OWL RF INSULATED CANNULAEGXI2017-06-27
429061510319803K150371Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRHGXI2015-07-30
429061894200823K141586OWL CANNULAEGXI2014-12-30
429061472252431K110593OWL RF PROBESGXI2011-05-05
429061508731725K102566OWL CANNULAEGXI2011-06-03
429061012556039K093185OWL UNIVERSAL RF SYSTEM URF-3AP (ML)GXD2010-01-22
429061329098225K073360PROPLATEGEI2007-12-19
429061379513871K062758OWL URF-3APGXD2006-09-27
429061251382670K021869OWL RADIOFREQUENCY SYSTEM, MODEL URF-2APGXD2002-07-01
429061379285504K010202OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBESGXD2001-10-31
429061226685132
429061376050855

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GXI52017-06-27
GXD42010-01-22
GEI12007-12-19

PMN#

GUDID#

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