COASTAL LIFE TECHNOLOGIES, INC.

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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) (10)

Premarket Exempt

No Yes

Clear

Surgimedics® - 00814716020104 Catalog Number :

Device Description : Smoke Evacuation Filter

Device Class : 2

Duns Number: 809254670

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

Surgimedics® - 00814716020128 Catalog Number :

Device Description : Smoke Evacuation Filter

Device Class : 2

Duns Number: 809254670

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

Surgimedics® - 00814716020135 Catalog Number :

Device Description : Smoke Evacuation Filter

Device Class : 2

Duns Number: 809254670

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

Surgimedics® - 00814716020142 Catalog Number :

Device Description : Smoke Evacuation Filter

Device Class : 2

Duns Number: 809254670

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

Surgimedics® - 00814716020159 Catalog Number :

Device Description : Smoke Evacuation Filter

Device Class : 2

Duns Number: 809254670

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

Surgimedics® - 00814716020166 Catalog Number :

Device Description : Smoke Evacuation Pre-filter

Device Class : 2

Duns Number: 809254670

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

Surgimedics® - 00814716020173 Catalog Number :

Device Description : Smoke Evacuation Pre-filter

Device Class : 2

Duns Number: 809254670

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

Surgimedics® - 00814716020180 Catalog Number :

Device Description : Smoke Evacuation Filter

Device Class : 2

Duns Number: 809254670

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

Surgimedics® - 00814716020197 Catalog Number :

Device Description : Smoke Evacuation Filter

Device Class : 2

Duns Number: 809254670

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

Surgimedics® - 00814716020203 Catalog Number :

Device Description : Smoke Evacuation Pre-filter

Device Class : 2

Duns Number: 809254670

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

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