STARMED CO.,LTD

Address:(Jungsan-dong, Daebang-Triplaon Business,Ilsandong-gu, Goyang-si Gyeonggi,KR

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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) (10)

Premarket Exempt

Clear

VIVA RF Electrode - 08809306768322 Catalog Number :

Device Description : The VIVA RF Electrode is a sterile, single-use electrosurgical accessory intende

Device Class :

Duns Number: 694699723

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

VIVA RF Electrode - 08809306768339 Catalog Number :

Device Description : The VIVA RF Electrode is a sterile, single-use electrosurgical accessory intende

Device Class :

Duns Number: 694699723

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

VIVA Pump - 08809306769015 Catalog Number : VP01

Device Description : The peristaltic pump, VIVA Pump, is used to provide the cooling of the electrode

Device Class : 2

Duns Number: 694699723

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Foot switch Single and Double - 08809306769022 Catalog Number :

Device Description : Single: Enables and disables RF output in manual control modeDouble: Increases(r

Device Class : 2

Duns Number: 694699723

Premarket Exempt : No

Product Code : GEI

Prescription Use : No

Device Count : 1

Foot switch Single - 08809306769046 Catalog Number :

Device Description : Enables and disables RF output in manual control mode

Device Class : 2

Duns Number: 694699723

Premarket Exempt : No

Product Code : GEI

Prescription Use : No

Device Count : 1

Foot switch Double - 08809306769053 Catalog Number :

Device Description : Increases(right) and decreases(left) RF output in 5watt step in manual control mode

Device Class : 2

Duns Number: 694699723

Premarket Exempt : No

Product Code : GEI

Prescription Use : No

Device Count : 1

VIVA combo RF Generator - 08809306769060 Catalog Number : VCS10

Device Description : The VIVA combo RF System consists of RF generator, active electrode, grounding p

Device Class : 2

Duns Number: 694699723

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

VIVA Pump - 08809306769107 Catalog Number :

Device Description : The peristaltic pump, VIVA Pump, is used to provide the cooling of the electrode

Device Class : 2

Duns Number: 694699723

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

VIVA combo RF Generator - 08809306769152 Catalog Number : VCS10

Device Description : The VIVA combo RF System consists of RF generator, active electrode, grounding p

Device Class : 2

Duns Number: 694699723

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

VIVA Pump - 08809306769176 Catalog Number : VP01

Device Description : The peristaltic pump, VIVA Pump, is used to provide the cooling of the electrode

Device Class : 2

Duns Number: 694699723

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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