BOVIE MEDICAL CORPORATION

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) (6) Burr, Corneal, Battery-Powered (HOG) (2) Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) (HOY) (1) Stimulator, Nerve (ETN) (1)

Premarket Exempt

No Yes

Clear

BOVIE - 00607151000011 Catalog Number : 0001

Device Description : OPHTHALMIC BURR

Device Class : 1

Duns Number: 079940465

Premarket Exempt : No

Product Code : HOG

Prescription Use : Yes

Device Count : 1

BOVIE - 00607151000028 Catalog Number : 0002

Device Description : EYE BUBBLE

Device Class : 1

Duns Number: 079940465

Premarket Exempt : No

Product Code : HOY

Prescription Use : Yes

Device Count : 1

Bovie - 00607151000035 Catalog Number : 0003

Device Description : NEURO-PULSE™ SURGICAL NERVE LOCATOR

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : ETN

Prescription Use : Yes

Device Count : 1

BOVIE - 00607151000073 Catalog Number : 0007

Device Description : REPLACEMENT NAIL DRILL TIP

Device Class : 1

Duns Number: 079940465

Premarket Exempt : No

Product Code : HOG

Prescription Use : Yes

Device Count : 1

Bovie - 00607151001254 Catalog Number : ESP6

Device Description : DISPOSABLE ELECTROSURGICAL ROCKER PENCIL

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

BOVIE - 00607151001414 Catalog Number : A1204C

Device Description : DISPERSIVE ELECTRODE CABLE, REUSABLE

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bovie - 00607151001438 Catalog Number : A801EU

Device Description : MONOPOLAR HANDPIECE WITH 8 FOOT DDOUBLE INSULATED CORD

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bovie - 00607151001445 Catalog Number : ESP1HN

Device Description : DISPOSABLE PUSH BUTTON PENCIL WITH BOVIE'S NEEDLE & HOLSTER

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bovie - 00607151001452 Catalog Number : ESP1HS

Device Description : DISPOSABLE ELECTROSURGICAL PUSH BUTTON PENCIL W/ HOLSTER AND SCRATCH PAD

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bovie - 00607151001476 Catalog Number : ESP6HN

Device Description : DISPOSABLE ROCKER SWITCH PENCIL WITH BOVIE'S NEEDLE AND HOLSTER

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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