DERMATOLOGIC LAB AND SUPPLY, 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

Delasco SaftEvac Filter - 00609960000633 Catalog Number : EV/P7

Device Description : FILTER PACK, SMOKE AND 7 FT TUBING, CLEAR. Medical Device.

Device Class : 2

Duns Number: 021628771

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

Delasco SaftEvac - 00609960000657 Catalog Number : EV

Device Description : Smoke Evacuator Unit and one filter pack, 110 Volt. Overall Dimensions: 11″ W × Smoke Evacuator Unit and one filter pack, 110 Volt. Overall Dimensions: 11″ W × 12″ H × 10″ D Weight: 18 pounds Cord: Detachable Hospital Grade Cord Enclosure: Grounded sheet steel, painted

Device Class : 2

Duns Number: 021628771

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

Delasco SaftEvac - 00609960000664 Catalog Number : EV/2

Device Description : Smoke Evacuator Unit and one filter pack, 220 Volt. Overall Dimensions: 11″ W × Smoke Evacuator Unit and one filter pack, 220 Volt. Overall Dimensions: 11″ W × 12″ H × 10″ D Weight: 18 pounds Cord: Detachable Hospital Grade Cord Enclosure: Grounded sheet steel, painted

Device Class : 2

Duns Number: 021628771

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

Delasco SaftEvac Filter - 00609960000671 Catalog Number : EV/R

Device Description : FILTERS, ONLY, VIRAL,SMOKE EVACUATOR, 1 EACH. Medical Device.

Device Class : 2

Duns Number: 021628771

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

Delasco SaftEvac Filter - 00609960000688 Catalog Number : EV/RC

Device Description : FILTER, VIRAL, W/CHARCOAL, 1 EACH. Medical Device.

Device Class : 2

Duns Number: 021628771

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

Geiger Smoke Evacuator Filter - 00609960000695 Catalog Number : FIL1-1

Device Description : OB/GYN FILTER PACK, FOR SMOKE EVACUATOR. Medical Device. The three pack is the FIL1-3.

Device Class : 2

Duns Number: 021628771

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

Geiger Smoke Evacuator Filter - 00609960000701 Catalog Number : FIL2-1

Device Description : FILTER PACK, SMOKE/LASER, 6ft, VIRAL FILTER. Medical Device. The three pack is the FIL2-3.

Device Class : 2

Duns Number: 021628771

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

Geiger Smoke Evacuator Filter - 00609960000718 Catalog Number : FIL3-1

Device Description : FILTER PACK, DUST, 6ft, EACH. Medical Device. Three pack is the FIL3-3.

Device Class : 2

Duns Number: 021628771

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

Geiger Smoke Evacuator Filter - 00609960000725 Catalog Number : FIL4-1

Device Description : FILTER PACK, 4 ft. HOSE AND VIRAL FILTER. Medical Device. 5 pack is the FIL4-5.

Device Class : 2

Duns Number: 021628771

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

Geiger Odor Filter - 00609960000756 Catalog Number : FIL-OFC-1

Device Description : S/E,ODOR FILTER START PK(HOS1,HOS5,OFC-EX,FIL,WND1. Medical Device.

Device Class : 2

Duns Number: 021628771

Premarket Exempt : Yes

Product Code : FYD

Prescription Use : Yes

Device Count : 1

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