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) (4) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (4) Tubing, Noninvasive (GAZ) (1) Tubing/Tubing With Filter, Insufflation, Laparoscopic (NKC) (1)

Premarket Exempt

No Yes

Clear

Buffalo Filter - 00815198011284 Catalog Number :

Device Description : Smoke Evacuation Tubing with 8 in integral wand and sponge guard

Device Class : 2

Duns Number: 787855907

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : Yes

Device Count : 1

ViroVac - 00815198011994 Catalog Number :

Device Description : Surgical Smoke Evacuator

Device Class : 2

Duns Number: 787855907

Premarket Exempt : No

Product Code : FYD

Prescription Use : Yes

Device Count : 1

PlumePort - 00815198012021 Catalog Number : PP010CS

Device Description : Laparoscopic Plume Filtration Device

Device Class : 1

Duns Number: 787855907

Premarket Exempt : Yes

Product Code : NKC

Prescription Use : Yes

Device Count : 1

ViroSafe VisiClear Filter - 00815198012052 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 :

Duns Number: 787855907

Premarket Exempt : No

Product Code : FYD

Prescription Use : Yes

Device Count : 1

VisiClear - 00815198012069 Catalog Number :

Device Description : Surgical Smoke Evacuator with Filter

Device Class :

Duns Number: 787855907

Premarket Exempt : No

Product Code : FYD

Prescription Use : Yes

Device Count : 1

VisiClear - 00815198012076 Catalog Number :

Device Description : Surgical Smoke Evacuator

Device Class :

Duns Number: 787855907

Premarket Exempt : No

Product Code : FYD

Prescription Use : Yes

Device Count : 1

PlumePen - 00815198012083 Catalog Number : PLP1001

Device Description : Smoke Plume Electrosurgical Pencil, Stainless steel blade

Device Class : 2

Duns Number: 787855907

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

PlumePen - 00815198012090 Catalog Number : PLP2001

Device Description : Smoke Plume Electrosurgical Pencil, Non-stick blade

Device Class : 2

Duns Number: 787855907

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

PlumePen - 00815198012106 Catalog Number : PLP1501

Device Description : Smoke Plume Electrosurgical Pencil, Stainless Steel blade

Device Class : 2

Duns Number: 787855907

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

PlumePen - 00815198012113 Catalog Number : PLP2501

Device Description : Smoke Plume Electrosurgical Pencil, Non-stick blade

Device Class : 2

Duns Number: 787855907

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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