dirostech.comOWL RF INSULATED CANNULAE
Diros Technology Inc.
DIROS TECHNOLOGY, INC.
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 8043398 | 3003630373 | DIROS TECHNOLOGY, INC. | 1 | N | 2026-01-01 | 120 GIBSON DRIVE MARKHAM Ontario CA L3R 2Z3 |
GUDID Contact Samples
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00825114000018 | OWL - OWL Radio Frequency RF Lesion Generator | 905-415-3440 | rbaker@dirostech.com |
| 00825114000032 | OWL - OWL RadioFrequency RF Lesion Generator | 905-415-3440 | RBAKER@DIROSTECH.COM |
| 00825114001770 | OWL - OWL STERILE SINGLE USE DISPOSABLE FACET DENERVATION R.F. PROBE/TEMPERATURE SENSOR FOR 5 CM CANNULA (THERMOCOUPLE) | 9054153440 | RBAKER@DIROSTECH.COM |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 42906 | 1952728973 | K170708 | OWL RF INSULATED CANNULAE | GXI | 2017-06-27 |
| 42906 | 1510319803 | K150371 | Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH | GXI | 2015-07-30 |
| 42906 | 1894200823 | K141586 | OWL CANNULAE | GXI | 2014-12-30 |
| 42906 | 1472252431 | K110593 | OWL RF PROBES | GXI | 2011-05-05 |
| 42906 | 1508731725 | K102566 | OWL CANNULAE | GXI | 2011-06-03 |
| 42906 | 1012556039 | K093185 | OWL UNIVERSAL RF SYSTEM URF-3AP (ML) | GXD | 2010-01-22 |
| 42906 | 1329098225 | K073360 | PROPLATE | GEI | 2007-12-19 |
| 42906 | 1379513871 | K062758 | OWL URF-3AP | GXD | 2006-09-27 |
| 42906 | 1251382670 | K021869 | OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP | GXD | 2002-07-01 |
| 42906 | 1379285504 | K010202 | OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES | GXD | 2001-10-31 |
| 42906 | 1226685132 | ||||
| 42906 | 1376050855 |
Product Codes Associated With Registrations
PMN
Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR And DTRH
DIROS TECHNOLOGY, INC.
OWL CANNULAE
DIROS TECHNOLOGY, INC.
OWL CANNULAE
DIROS TECHNOLOGY, INC.
OWL RF PROBES
DIROS TECHNOLOGY, INC.
OWL UNIVERSAL RF SYSTEM URF-3AP (ML)
DIROS TECHNOLOGY, INC.
OWL URF-3AP
DIROS TECHNOLOGY, INC.
OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP
DIROS TECHNOLOGY, INC.
GUDID
OWL - OWL STERILE SINGLE USE DISPOSABLE RF INSULATED HYBRID CANNULA (22Ga.) 60MM LONG, 10MM BARE TIP
2025-07-16
OWL - OWL RadioFrequency RF Lesion Generator
2023-06-19
OWL - OWL STERILE SINGLE USE DISPOSABLE FACET DENERVATION R.F. PROBE/TEMPERATURE SENSOR FOR 5 CM CANNULA (THERMOCOUPLE)
2016-09-23
OWL - OWL STERILE SINGLE USE DISPOSABLE RF INSULATED HYBRID CANNULA (20Ga.) 50mm LONG, 5mm BARE TIP
2016-09-01
OWL - OWL STERILE SINGLE USE DISPOSABLE RF INSULATED CANNULA (22 Ga.), 50 mm LONG, 5 mm BARE TIP
2016-09-01
OWL - OWL STERILE SINGLE USE DISPOSABLE RF INSULATED HYBRID CANNULA (16GA), 150MM LONG, 6MM BARE TIP
2016-09-01
OWL - OWL STERILE SINGLE USE DISPOSABLE SHARP CURVED RF INSULATED CANNULA (20 Ga.), 54mm LONG, 10MM BARE TIP
2016-10-03
OWL - OWL Radio Frequency RF Lesion Generator
2016-09-01
OWL - OWL MULTI-LESION ADAPTER, MODEL MLA-4
2016-09-23
OWL - PLASTIC FOOTSWITCH FOR URF-3AP
2016-09-23
OWL - OWL STERILE SINGLE USE DISPOSABLE FACET DENERVATION R.F. PROBE/TEMPERATURE SENSOR FOR 5 CM CANNULA (THERMOCOUPLE)
2016-09-23
OWL - OWL STERILE SINGLE USE DISPOSABLE FACET DENERVATION R.F. PROBE/TEMPERATURE SENSOR FOR 10 CM CANNULA (THERMOCOUPLE)
2016-09-01
OWL - OWL STERILE SINGLE USE DISPOSABLE FACET DENERVATION R.F. PROBE/TEMPERATURE SENSOR FOR 15 CM CANNULA (THERMOCOUPLE)
2016-09-01
OWL - OWL STERILE SINGLE USE FACET DENERVATION R.F. PROBE/TEMPERATURE SENSOR FOR 20 CM CANNULA (THERMOCOUPLE)
2016-09-01
OWL - OWL STERILE SINGLE USE DISPOSABLE FACET DENERVATION R.F. PROBE/TEMPERATURE SENSOR FOR 5 CM CANNULA (THERMISTOR)
2016-09-01
OWL - OWL STERILE SINGLE USE DISPOSABLE FACET DENERVATION R.F. PROBE/TEMPERATURE SENSOR FOR 5 CM CANNULA (THERMOCOUPLE)
2016-09-01
OWL - OWL STERILE SINGLE USE DISPOSABLE FACET DENERVATION R.F. PROBE/TEMPERATURE SENSOR FOR 10 CM CANNULA (THERMISTOR)
2016-09-01
OWL - OWL STERILE SINGLE USE DISPOSABLE FACET DENERVATION R.F. PROBE/TEMPERATURE SENSOR FOR 10 CM CANNULA (THERMOCOUPLE)
2016-09-01
OWL - OWL STERILE SINGLE USE DISPOSABLE FACET DENERVATION R.F. PROBE/TEMPERATURE SENSOR FOR 15 CM CANNULA (THERMISTOR)
2016-09-01
OWL - OWL STERILE SINGLE USE DISPOSABLE FACET DENERVATION R.F. PROBE/TEMPERATURE SENSOR FOR 15 CM CANNULA (THERMOCOUPLE)
2016-09-01
OWL - OWL STERILE SINGLE USE DISPOSABLE FACET DENERVATION R.F. PROBE/TEMPERATURE SENSOR FOR 20 CM CANNULA (THERMISTOR)
2016-09-01
OWL - OWL STERILE SINGLE USE FACET DENERVATION R.F. PROBE/TEMPERATURE SENSOR FOR 20 CM CANNULA (THERMOCOUPLE)
2016-09-01
OWL - OWL GD-PAD PATIENT RETURN ELECTRODE, CORDED
2016-09-01
OWL - OWL GD-PAD PATIENT RETURN ELECTRODE, NON-CORDED
2016-09-01
OWL - OWL TASKER INTRACRANIAL ELECTRODE SET (18 GA.)
2016-09-01
OWL - OWL REUSABLE TASKER THALAMOTOMY LESION ELECTRODE,TEMPERATURE SENSING
2016-09-01
OWL - SET OF 2, PROTECTOR TUBES FOR STORING ELECTRODE
2016-09-01
OWL - SET OF 2, DEPTH STOPPERS
2016-09-01
OWL - AUTOCLAVE CASE
2016-09-23
OWL - OWL GASSERIAN GANGLION SET (TRIGEMINAL SET OR TIC SET) (Thermistor)
2016-09-01
OWL - OWL GASSERIAN GANGLION R.F. PROBE/TEMPERATURE SENSOR
2016-09-01
OWL - SET OF 2, GASSERIAN GANGLION LESION ELECTRODES AND STYLETS
2016-09-23
OWL - OWL GASSERIAN GANGLION SET (Thermocouple)
2016-09-23
OWL - OWL GASSERIAN GANGLION R.F. PROBE/TEMPERATURE SENSOR
2016-09-23
OWL - OWL THERMISTOR CORDOTOMY ELECTRODE SET
2016-09-01
OWL - OWL CORDOTOMY ELECTRODE AND TEMPERATURE SENSING PROBE
2016-09-23
OWL - SET OF 2, 18 GAUGE SPINAL NEEDLES AND STYLETS
2016-09-23
OWL - PROTECTOR TUBE FOR CORDOTOMY ELECTRODE AND TEMPERATURE SENSING PROBE
2016-09-23
OWL - OWL THERMISTOR D.R.E.Z SET (Thermistor)
2016-09-01
OWL - OWL FACET RHIZOTOMY SET (SPINAL RHIZOTOMY SET)
2016-09-01