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) (8) Tubing, Noninvasive (GAZ) (2)

Premarket Exempt

No Yes

Clear

Bovie - 00607151001483 Catalog Number : ESP7HS

Device Description : DISPOSABLE ELECTROSURGICAL FOOT CONTROL PENCIL W/ HOLSTER & SCRATCH PAD

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bovie - 00607151001490 Catalog Number : ESP7HN

Device Description : DISPOSABLE FOOT CONTROL 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

Bovie - 00607151001506 Catalog Number : A1203W

Device Description : FOOTSWITCH / PEDAL WATERPROOF

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

BOVIE - 00607151001575 Catalog Number : A1205A

Device Description : ESU FOOT CONTROL ADAPTER

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bovie - 00607151001612 Catalog Number : SEVL

Device Description : VACUUM HOSE/ TUBING 7/8" (2.2225 cm) X 6' (1.8288m) WITH 7/8" (2.22cm) TO 3/8” ( VACUUM HOSE/ TUBING 7/8" (2.2225 cm) X 6' (1.8288m) WITH 7/8" (2.22cm) TO 3/8” (.952cm) ADAPTER WITH 3/8” (.952cm) X 4’ (121.92cm) TUBING

Device Class : 2

Duns Number: 079940465

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : Yes

Device Count : 1

Bovie - 00607151001667 Catalog Number : SERF

Device Description : REDUCER FITTING 7/8" (2.22cm) TO ¼" (.63cm) X WITH ¼" (.63cm) X 24” (60.96CM) M REDUCER FITTING 7/8" (2.22cm) TO ¼" (.63cm) X WITH ¼" (.63cm) X 24” (60.96CM) MEDICAL (PVC) TUBING (10 PER POUCH)

Device Class : 2

Duns Number: 079940465

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : Yes

Device Count : 1

Bovie - 00607151001674 Catalog Number : ESRSC

Device Description : DISPOSABLE SOLID ADULT RETURN ELECTRODE WITH CABLE

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bovie - 00607151001681 Catalog Number : ESRS

Device Description : DISPOSABLE SOLID ADULT RETURN ELECTRODE

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bovie - 00607151001698 Catalog Number : ESPH

Device Description : DISPOSABLE ELECTROSURGICAL PENCIL WITH HOLSTER

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bovie - 00607151001704 Catalog Number : ESP6HS

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

Device Class : 2

Duns Number: 079940465

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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