BOVIE MEDICAL CORPORATION

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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

Electrocautery, Gynecologic (And Accessories) (HGI) (7) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (3)

Premarket Exempt

No Yes

Clear

Bovie - 00607151002626 Catalog Number : ESLK

Device Description : ELECTROSURGICAL LOOP KIT

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 1

Bovie - 00607151002855 Catalog Number : ES31

Device Description : LLETZ LOOP ELECTRODE (20MM X 20MM)

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 1

Bovie - 00607151002985 Catalog Number : ES24

Device Description : ELECTRODE 3/8'' TUNGSTEN LOOP

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 1

BOVIE - 00607151003043 Catalog Number : ES60

Device Description : SUPERCUT™ FINE NEEDLE ELECTRODE, 3cm

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 1

BOVIE - 00607151003050 Catalog Number : ES62

Device Description : SUPERCUT™ FINE NEEDLE ELECTRODE, 4.5cm

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 1

BOVIE - 00607151003111 Catalog Number : ES61

Device Description : SUPERCUT™ MODIFIED FINE NEEDLE ELECTRODE, 3cm

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 1

BOVIE - 00607151003128 Catalog Number : ES63

Device Description : SUPERCUT™ MODIFIED FINE NEEDLE ELECTRODE, 4.5cm

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 1

Bovie - 00607151003135 Catalog Number : AR00

Device Description : ARTHROSCOPY ELECTRODE, HOOK 90°

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bovie - 00607151003142 Catalog Number : AR01

Device Description : ARTHROSCOPY ELECTRODE, HOOK 45°

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bovie - 00607151003159 Catalog Number : AR02

Device Description : ARTHROSCOPY BLADE ELECTRODE (ACROMIOPLASTY), INSULATED

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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