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) (4) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (2)

Premarket Exempt

No Yes

Clear

OB/GYN FILTER PACK - 10609960001026 Catalog Number : 72102

Device Description : OB/GYN FILTER PACK, COOPER, PACK/3. Medical Device.

Device Class :

Duns Number: 021628771

Premarket Exempt : Yes

Product Code : FYD

Prescription Use : No

Device Count : 3

Electrolite - 10609960001248 Catalog Number :

Device Description : E, ELECTRODE, ELECTROLITE SAMPLE PACK OF 50. Medical device.

Device Class :

Duns Number: 021628771

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 50

Delasco Electrosurgical Handpiece Sheath - 10609960001255 Catalog Number :

Device Description : SHEATHS, ELECTROSURGICAL, 26100 SAMPLE PK5. A non-sterile sheath designed to fi SHEATHS, ELECTROSURGICAL, 26100 SAMPLE PK5. A non-sterile sheath designed to fit over most electrosurgical handpieces. Latex-free, 8" long with 7/8" diameter opening. Sample pack of 5. Medical device.

Device Class :

Duns Number: 021628771

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 5

Premier Filter Pack for Premier Evacuator - D69190062900 Catalog Number : 9006290

Device Description : Premier Filter Pack for Premier Evacuator. Contains five disposable Premier filters.

Device Class : 2

Duns Number: 021628771

Premarket Exempt : No

Product Code : FYD

Prescription Use : Yes

Device Count : 1

Premier Evacuator 220V Air Filtration System - D69190062980 Catalog Number : 9006298

Device Description : Premier Evacuator 220V Air Filtration System. Contains one Premier Evacuator 22 Premier Evacuator 220V Air Filtration System. Contains one Premier Evacuator 220V unit, one detachable cord, and Disposable Filter Pack (5 filters - reorder number 9006290).

Device Class : 2

Duns Number: 021628771

Premarket Exempt : No

Product Code : FYD

Prescription Use : Yes

Device Count : 1

Premier Evacuator 110V Air Filtration System - D69190063000 Catalog Number : 9006300

Device Description : Premier Evacuator 110V Air Filtration System. Contains one Premier Evacuator 11 Premier Evacuator 110V Air Filtration System. Contains one Premier Evacuator 110V unit, one detachable cord, and Disposable Filter Pack (5 filters - reorder number 9006290).

Device Class : 2

Duns Number: 021628771

Premarket Exempt : No

Product Code : FYD

Prescription Use : Yes

Device Count : 1

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