DERMATOLOGIC LAB AND SUPPLY, INC.

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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) (7) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (3)

Premarket Exempt

No Yes

Clear

Delasco Bipolar Forceps - 00609960000480 Catalog Number : 26407

Device Description : FORCEPS,BIPOLAR,GERALD,7in STRGHT,1.0MM,SMOOTH TIP. Medical Device.

Device Class : 2

Duns Number: 021628771

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Delasco Bipolar Forceps - 00609960000497 Catalog Number : 26408

Device Description : FORCEPS,BIPOLAR,GERALD,7 1/4inBAYONET,1.0MM,SMOOTH. Medical Device.

Device Class : 2

Duns Number: 021628771

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Delasco Bipolar Forceps Cord - 00609960000503 Catalog Number : 26409

Device Description : CABLE, CONNECTING FOR BIPOLAR FORCEPS,ELECTRICATOR. Medical Device.

Device Class : 2

Duns Number: 021628771

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Geiger Smoke Evacuator - 00609960000510 Catalog Number : SA-1A

Device Description : Smoke Evacuator Unit and one FIL2 filter pack, 110 Volt. Primary Power Control: Smoke Evacuator Unit and one FIL2 filter pack, 110 Volt. Primary Power Control: On/Off Switch — Illuminated when On Secondary Power Control: Maintained Foot Switch (optional) Noise Level: 60-65 db at 1 meter 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

Geiger Smoke Evacuator - 00609960000527 Catalog Number : SA-1A2

Device Description : Smoke Evacuator Unit and one FIL2 filter pack, 220 Volt. Primary Power Control: Smoke Evacuator Unit and one FIL2 filter pack, 220 Volt. Primary Power Control: On/Off Switch — Illuminated when On Secondary Power Control: Maintained Foot Switch (optional) Noise Level: 60-65 db at 1 meter 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

Geiger Smoke Evacuator Filter - 00609960000534 Catalog Number : FIL1-1

Device Description : OB/GYN FILTER PACK, FOR SMOKE EVACUATOR

Device Class : 2

Duns Number: 021628771

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

Geiger Smoke Evacuator Filter - 00609960000541 Catalog Number : FIL2-1

Device Description : FILTER PACK, SMOKE/LASER, 6ft TUBE, VIRAL FILTER

Device Class : 2

Duns Number: 021628771

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

Geiger Smoke Evacuator Filter - 00609960000558 Catalog Number : FIL3-1

Device Description : FILTER PACK, DUST, 6ft TUBE

Device Class : 2

Duns Number: 021628771

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

Geiger Smoke Evacuator Filter - 00609960000565 Catalog Number : FIL4-1

Device Description : FILTER PACK, 4 ft. HOSE AND VIRAL FILTER

Device Class : 2

Duns Number: 021628771

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

Delasco SaftEvac Filter - 00609960000626 Catalog Number : EV/P

Device Description : FILTER PACK, SMOKE AND 6 FT TUBING, CLEAR. Medical Device.

Device Class : 2

Duns Number: 021628771

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

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