RF Medical Co.,Ltd.

Address:#502~#507,#511,#601, 254 Beotkkot-ro, Geumcheon-gu,Seoul,KR

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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

Electrosurgical, Cutting & Coagulation & Accessories (GEI) (8) Biopsy Needle Guide Kit (OIJ) (2)

Premarket Exempt

No Yes

Clear

Moving-Shot Guide - 08800142915079 Catalog Number :

Device Class : 2

Duns Number: 690514869

Premarket Exempt : Yes

Product Code : OIJ

Prescription Use : No

Device Count : 1

2-Pin Dispersive Electrode cable - 08809295145777 Catalog Number :

Device Description : 2-Pin connecting cable for dispersive electrode

Device Class : 2

Duns Number: 690514869

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Single channel Foot Switch - 08809295145807 Catalog Number :

Device Description : The foot switch is used to turn RF energy on/off and to start/stop the cooling p The foot switch is used to turn RF energy on/off and to start/stop the cooling pump operation.

Device Class : 2

Duns Number: 690514869

Premarket Exempt : No

Product Code : GEI

Prescription Use : No

Device Count : 1

RF ABLATION SYSTEM V-1000 - 08809295147030 Catalog Number :

Device Description : The RF Ablation System V-1000 is a microprocessor-based generator. This generato The RF Ablation System V-1000 is a microprocessor-based generator. This generator provides up to 140 W of RF energy to be used for coagulation & ablation of vessel, tissue and bone.

Device Class : 2

Duns Number: 690514869

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Cooling pump - 08809295147054 Catalog Number :

Device Description : The Cooling pump RFP-300 is used to cooling of the electrodes by circulating sal The Cooling pump RFP-300 is used to cooling of the electrodes by circulating saline solution.

Device Class : 2

Duns Number: 690514869

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Moving-shot guide - 08809295149966 Catalog Number :

Device Description : Needle guide

Device Class : 2

Duns Number: 690514869

Premarket Exempt : Yes

Product Code : OIJ

Prescription Use : Yes

Device Count : 1

RFT Electrode - 08809559960061 Catalog Number :

Device Description : The RFT electrode is sterile single use mono-polar electrode for electrosurgical unit.

Device Class : 2

Duns Number: 690514869

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

RFT Electrode - 08809559960078 Catalog Number :

Device Description : The RFT electrode is sterile single use mono-polar electrode for electrosurgical unit.

Device Class : 2

Duns Number: 690514869

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

RFT Electrode - 08809559960139 Catalog Number :

Device Description : The RFT electrode is sterile single use mono-polar electrode for electrosurgical unit.

Device Class : 2

Duns Number: 690514869

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

THYBLATE™ - 08809559960146 Catalog Number :

Device Class : 2

Duns Number: 690514869

Premarket Exempt : Yes

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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