Diros Technology Inc

Address:120 GIBSON DRIVE,MARKHAM Ontario,CA

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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

Cable, Electrode (IKD) (8) Generator, Lesion, Radiofrequency (GXD) (2)

Premarket Exempt

No Yes

Clear

OWL - 00825114000018 Catalog Number : 653-100

Device Description : OWL Radio Frequency RF Lesion Generator

Device Class : 2

Duns Number: 202738675

Premarket Exempt : No

Product Code : GXD

Prescription Use : No

Device Count : 1

OWL - 00825114000025 Catalog Number : 653-100-MLA

Device Description : OWL MULTI-LESION ADAPTER, MODEL MLA-4

Device Class : 2

Duns Number: 202738675

Premarket Exempt : No

Product Code : GXD

Prescription Use : Yes

Device Count : 1

OWL - 00825114000056 Catalog Number : 463-103-TM-S

Device Description : CABLE FOR URF-3AP TO THERMISTOR R.F. PROBE/TEMPERATURE SENSOR

Device Class : 2

Duns Number: 202738675

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

OWL - 00825114000063 Catalog Number : 463-104-TS-S

Device Description : CABLE FOR URF-3AP TO TASKER THALAMOTOMY STIMULATING ELECTRODE

Device Class : 2

Duns Number: 202738675

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

OWL - 00825114000070 Catalog Number : 463-103-TC-S

Device Description : CABLE FOR URF-3AP TO THERMOCOUPLE R.F. PROBE/TEMPERATURE SENSOR

Device Class : 2

Duns Number: 202738675

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

OWL - 00825114000094 Catalog Number : 463-103-NT-S

Device Description : CABLE FOR URF-3AP TO R.F. PROBE (NO TEMPERATURE SENSING)

Device Class : 2

Duns Number: 202738675

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

OWL - 00825114000100 Catalog Number : 463-103-DT-S

Device Description : CABLE FOR URF-3AP TO discTRODE AND NON-RF PROBE/TEMPERATURE SENSOR

Device Class : 2

Duns Number: 202738675

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

OWL - 00825114000117 Catalog Number : 463-103-SC-S

Device Description : CABLE FOR URF-3AP TO SPINECATH

Device Class : 2

Duns Number: 202738675

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

OWL - 00825114000124 Catalog Number : 463-103-HCT-S

Device Description : CABLE FOR URF-3AP TO HYBRID CANNULA OR THERMOCOUPLE DISPOSABLE RF PROBE/TEMPERATURE SENSOR

Device Class : 2

Duns Number: 202738675

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

OWL - 00825114000131 Catalog Number : 463-103-BPHCT-S

Device Description : CABLE FOR URF-3AP TO BIPOLAR HYBRID CANNULA or OWL DISPOSABLE THERMOCOUPLE RF PR CABLE FOR URF-3AP TO BIPOLAR HYBRID CANNULA or OWL DISPOSABLE THERMOCOUPLE RF PROBE/TEMPERATURE SENSOR

Device Class : 2

Duns Number: 202738675

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

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