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 - 00825114000759 Catalog Number : 465-003-S

Device Description : SET OF 2, 18 GAUGE SPINAL NEEDLES AND STYLETS

Device Class : 2

Duns Number: 202738675

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

OWL - 00825114000766 Catalog Number : 463-003-C

Device Description : PROTECTOR TUBE FOR CORDOTOMY ELECTRODE AND TEMPERATURE SENSING PROBE

Device Class : 2

Duns Number: 202738675

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

OWL - 00825114000780 Catalog Number : 463-070-S

Device Description : OWL THERMISTOR D.R.E.Z SET (Thermistor)

Device Class : 2

Duns Number: 202738675

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

OWL - 00825114000827 Catalog Number : 463-010-S

Device Description : OWL FACET RHIZOTOMY SET (SPINAL RHIZOTOMY SET)

Device Class : 2

Duns Number: 202738675

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

OWL - 00825114000834 Catalog Number : 463-013-S

Device Description : SET OF 2, FACET RHIZOTOMY LESION ELECTRODES

Device Class : 2

Duns Number: 202738675

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

OWL - 00825114000841 Catalog Number : 463-014-S

Device Description : SET OF 4, 14 GAUGE STAINLESS STEEL NEEDLES AND STYLETS

Device Class : 2

Duns Number: 202738675

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

OWL - 00825114000858 Catalog Number : 463-011-S

Device Description : FACET RHIZOTOMY R.F. PROBE/TEMPERATURE SENSOR

Device Class : 2

Duns Number: 202738675

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

OWL - 00825114000872 Catalog Number : 466-050-S

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

Device Class : 2

Duns Number: 202738675

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

OWL - 00825114000889 Catalog Number : 466-005-S

Device Description : OWL FACET DENERVATION THERMISTOR 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 - 00825114000902 Catalog Number : 466-PB3-S

Device Description : AUTOCLAVE CASE

Device Class : 2

Duns Number: 202738675

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

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