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) (5) Electrode, Depth (GZL) (2) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (2) Generator, Lesion, Radiofrequency (GXD) (1)

Premarket Exempt

No Yes

Clear

OWL - 00825114000414 Catalog Number : 473-500

Device Description : OWL TEMPERATURE TESTER FOR URF-2AP

Device Class : 2

Duns Number: 202738675

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

OWL - 00825114000421 Catalog Number : 653-447

Device Description : PLASTIC FOOTSWITCH FOR URF-3AP

Device Class : 2

Duns Number: 202738675

Premarket Exempt : No

Product Code : GXD

Prescription Use : Yes

Device Count : 1

OWL - 00825114000476 Catalog Number : C463-103-DT-S2F-S

Device Description : CABLE FOR URF-3AP TO OWL DISPOSABLE TC RF PROBE 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 - 00825114000483 Catalog Number : D7506

Device Description : OWL GD-PAD PATIENT RETURN ELECTRODE, CORDED

Device Class :

Duns Number: 202738675

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

OWL - 00825114000490 Catalog Number : D7506NC

Device Description : OWL GD-PAD PATIENT RETURN ELECTRODE, NON-CORDED

Device Class :

Duns Number: 202738675

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

OWL - 00825114000520 Catalog Number : 463-DGP01-S(IEC)

Device Description : CABLE FOR URF-1(NON-IEC) TO OWL GD-PAD NON-CORDED PART# D7506NC/D7507NC

Device Class : 2

Duns Number: 202738675

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

OWL - 00825114000537 Catalog Number : 463-DGP01-S

Device Description : CABLE FOR URF-1(NON-IEC) WITH CLAMP TO OWL GD-PAD NON-CORDED PART # D7506NC/D7507NC

Device Class : 2

Duns Number: 202738675

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

OWL - 00825114000544 Catalog Number : C473-004-S

Device Description : DIROS ADAPTER (4MM BANANA PIN TO OWL GD-PAD CORDED) FOR COSMAN, NEUROTHERM, RADI DIROS ADAPTER (4MM BANANA PIN TO OWL GD-PAD CORDED) FOR COSMAN, NEUROTHERM, RADIONICS, STRYKER, & SMITH & NEPHEW RF DEVICES

Device Class : 2

Duns Number: 202738675

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

OWL - 00825114000599 Catalog Number : 468-100-S

Device Description : OWL TASKER INTRACRANIAL ELECTRODE SET (18 GA.)

Device Class : 2

Duns Number: 202738675

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

OWL - 00825114000605 Catalog Number : 468-101-S

Device Description : OWL REUSABLE TASKER THALAMOTOMY LESION ELECTRODE,TEMPERATURE SENSING

Device Class : 2

Duns Number: 202738675

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

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