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

Electrosurgical, Cutting & Coagulation & Accessories (GEI) (5) Electrocautery, Gynecologic (And Accessories) (HGI) (4) Unit, Cryosurgical, Accessories (GEH) (1)

Premarket Exempt

No Yes

Clear

ICEOUT™ - 10607151012127 Catalog Number : CRY25

Device Description : ICEOUT PORTABLE CRYOSURGICAL SYSTEM, (2) 80 ML AEROSOL DISPENSERS AND (60) 2MM & ICEOUT PORTABLE CRYOSURGICAL SYSTEM, (2) 80 ML AEROSOL DISPENSERS AND (60) 2MM & 5 MM APPLICATORS

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

BOVIE® - 10607151012172 Catalog Number : H10012

Device Description : H-TYPE SHARP TIP DISPOSABLE DERMAL ELECTRODE, NON-STERILE

Device Class :

Duns Number: 079940465

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 100

BOVIE® - 10607151012189 Catalog Number : H10112

Device Description : H-TYPE BLUNT TIP DISPOSABLE DERMAL ELECTRODE, NON-STERILE

Device Class :

Duns Number: 079940465

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 100

Bovie - 10607151018020 Catalog Number : A802

Device Description : DISPERSIVE ELECTRODE AND CABLE; REUSABLE FOR A800 AND A1200 GENERATORS

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

BOVIE - 10607151018044 Catalog Number : A804

Device Description : DERMAL TIP ELECTRODE, SHARP TIP

Device Class :

Duns Number: 079940465

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 100

BOVIE - 10607151018068 Catalog Number : A806

Device Description : DERMAL TIP ELECTRODE, BLUNT TIP

Device Class :

Duns Number: 079940465

Premarket Exempt : No

Product Code : HGI

Prescription Use : Yes

Device Count : 100

BOVIE - 10607151018204 Catalog Number : A820

Device Description : BIPOLAR FORCEPS 7.25'' FINE TIP

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

BOVIE - 10607151018211 Catalog Number : A821

Device Description : BIPOLAR FORCEPS 8'' BAYONET 2MM TIP

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

BOVIE - 10607151018228 Catalog Number : A822

Device Description : BIPOLAR FORCEPS 7'' STRAIGHT FINE TIP

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

BOVIE - 10607151018235 Catalog Number : A823

Device Description : BIPOLAR FORCEPS 7'' CURVED FINE TIP

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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