Buffalo Filter

Address:95 CORPORATE DRIVE,Trumbull,CT,06611,US

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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

Apparatus, Exhaust, Surgical (FYD) (6) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (3) Tubing, Noninvasive (GAZ) (1)

Premarket Exempt

No Yes

Clear

GoldVac Slim - 00815198012397 Catalog Number : 60-7670-001

Device Description : Push Button Smoke Evacuation Pencil, 15ft

Device Class : 2

Duns Number: 787855907

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

ClearView - 00815198012403 Catalog Number : 60-8585-120

Device Description : Smoke Evacuation Unit

Device Class : 2

Duns Number: 787855907

Premarket Exempt : No

Product Code : FYD

Prescription Use : Yes

Device Count : 1

ClearView - 00815198012410 Catalog Number : 60-8585-230

Device Description : Smoke Evacuation Unit

Device Class : 2

Duns Number: 787855907

Premarket Exempt : No

Product Code : FYD

Prescription Use : Yes

Device Count : 1

ClearView - 00815198012427 Catalog Number :

Device Description : Smoke Evacuation Filter - 3-port 1/4 in (6.4mm), 3/8 in (9.5 mm), and 7/8 in (22 mm)

Device Class : 2

Duns Number: 787855907

Premarket Exempt : No

Product Code : FYD

Prescription Use : Yes

Device Count : 1

ClearView - 00815198012434 Catalog Number :

Device Description : Filter Fluid Trap

Device Class :

Duns Number: 787855907

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : Yes

Device Count : 10

ClearView - 00815198012441 Catalog Number :

Device Description : Automatic Activation Device

Device Class : 2

Duns Number: 787855907

Premarket Exempt : No

Product Code : FYD

Prescription Use : Yes

Device Count : 1

PlumePen - 00815198012465 Catalog Number : PROTIP400

Device Description : Disposable Capture Port Tip for Smoke Plume Electrosurgical Pencil

Device Class : 2

Duns Number: 787855907

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

PlumePen - 00815198012472 Catalog Number : PROTIP600

Device Description : Disposable Capture Port Tip for Smoke Plume Electrosurgical Pencil

Device Class : 2

Duns Number: 787855907

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

TeleVac2 - 00815198012489 Catalog Number :

Device Description : Multi-Port ULPA Filter

Device Class :

Duns Number: 787855907

Premarket Exempt : No

Product Code : FYD

Prescription Use : Yes

Device Count : 1

Buffalo Filter - 00815198012496 Catalog Number :

Device Description : Direct Connect Cable

Device Class : 2

Duns Number: 787855907

Premarket Exempt : No

Product Code : FYD

Prescription Use : Yes

Device Count : 1

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