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

Probe, Radiofrequency Lesion (GXI) (10)

Premarket Exempt

No Yes

Clear

OWL - 00825114000919 Catalog Number : 467-050-TC-S

Device Description : OWL FACET DENERVATION SET (5CM) (Thermocouple)

Device Class : 2

Duns Number: 202738675

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

OWL - 00825114000926 Catalog Number : 467-005-TC-S

Device Description : OWL FACET DENERVATION THERMOCOUPLE R.F. PROBE/TEMPERATURE SENSOR, 5CM

Device Class : 2

Duns Number: 202738675

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

OWL - 00825114000933 Catalog Number : 466-003-S

Device Description : PROTECTOR TUBE FOR R.F. PROBE/TEMPERATURE SENSOR

Device Class : 2

Duns Number: 202738675

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

OWL - 00825114000971 Catalog Number : 466-004/50/4-R-S

Device Description : OWL RE-USABLE RF INSULATED CANNULA (21 Ga.) 50mm LONG, 4mm BARE TIP

Device Class : 2

Duns Number: 202738675

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

OWL - 00825114001008 Catalog Number : 466-100-S

Device Description : OWL FACET DENERVATION SET (10CM) (THERMISTOR)

Device Class : 2

Duns Number: 202738675

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

OWL - 00825114001015 Catalog Number : 466-010-S

Device Description : OWL FACET DENERVATION THERMISTOR R.F. PROBE/TEMPERATURE SENSOR, 10CM

Device Class : 2

Duns Number: 202738675

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

OWL - 00825114001046 Catalog Number : 467-100-TC-S

Device Description : OWL FACET DENERVATION SET (10CM) (Thermocouple)

Device Class : 2

Duns Number: 202738675

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

OWL - 00825114001053 Catalog Number : 467-010-TC-S

Device Description : OWL FACET DENERVATION THERMOCOUPLE R.F. PROBE/TEMPERATURE SENSOR, 10CM

Device Class : 2

Duns Number: 202738675

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

OWL - 00825114001107 Catalog Number : 466-004/100/5-R-S

Device Description : OWL RE-USABLE RF INSULATED CANNULA (21 Ga.) 100mm LONG, 5mm BARE TIP

Device Class : 2

Duns Number: 202738675

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

OWL - 00825114001152 Catalog Number : 466-004/100/10-BRC-S

Device Description : OWL RE-USABLE BLUNT CURVED RF INSULATED CANNULA, (20Ga) 10cm LONG, 10MM BARE TIP

Device Class : 2

Duns Number: 202738675

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

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