ACUDERM, INC.

Address:8 Ridgedale Avenue,Cedar Knolls,NJ,07927,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) (3) Powered Laser Surgical Instrument (GEX) (3) Culture Media, Selective And Non-Differential (JSJ) (2) Scissors, General, Surgical (LRW) (2)

Premarket Exempt

Yes No

Clear

ACU-EVAC - 10814105020460 Catalog Number :

Device Description : Top of the line surgical smoke evacuator. Specifically designed for use with erb Top of the line surgical smoke evacuator. Specifically designed for use with erbium smoke. Also suitable for use with CO2, hair removal, and other laser or electrosurgical units in open procedures or with reducer for handpiece or 220vac motor

Device Class : 2

Duns Number: 071426803

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

ACU-EVAC - 10814105020491 Catalog Number :

Device Description : Includes TX Nozzle, preliminary filter, 8" hose section assembly, connects to Ho Includes TX Nozzle, preliminary filter, 8" hose section assembly, connects to Hose, Intended for short procedures of up to 15 minutes duration

Device Class : 2

Duns Number: 071426803

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

ACU-EVAC - 10814105020507 Catalog Number :

Device Description : Includes TX Nozzle, preliminary filter, 18" hose section assembly, connects to H Includes TX Nozzle, preliminary filter, 18" hose section assembly, connects to Hose, Intended for long procedures of up to 1 hour duration

Device Class : 2

Duns Number: 071426803

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

ACU-GUARD - 10814105020859 Catalog Number :

Device Description : Acu-Guard II easy fit disposable clear sheaths non-sterile packaged 50/box

Device Class : 2

Duns Number: 071426803

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

ACU-GUARD - 10814105020866 Catalog Number :

Device Description : Acu-Guard II easy fit disposable clear sheaths non-sterile packaged 50/box

Device Class : 2

Duns Number: 071426803

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

ACU-GUARD - 10814105020873 Catalog Number :

Device Description : Acu-Guard II easy fit disposable clear sheaths sterile packaged 50/box

Device Class : 2

Duns Number: 071426803

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Acu-Scissors - 10814105021108 Catalog Number :

Device Description : Acu-Scissors, Straight, Sterile, 5/Bx

Device Class : 1

Duns Number: 071426803

Premarket Exempt : Yes

Product Code : LRW

Prescription Use : No

Device Count : 5

Acu-Scissors - 10814105021115 Catalog Number :

Device Description : Acu-Scissors, Curved, Sterile, 5/Bx

Device Class : 1

Duns Number: 071426803

Premarket Exempt : Yes

Product Code : LRW

Prescription Use : No

Device Count : 5

ACU-DTM - 10814105021207 Catalog Number :

Device Description : ACU-DTM, Dermatophyte Test Medium, 24/bX

Device Class : 1

Duns Number: 071426803

Premarket Exempt : No

Product Code : JSJ

Prescription Use : No

Device Count : 24

ACU-DTM - 10814105021214 Catalog Number :

Device Description : ACU-DTM, Dermatophyte Test Medium, 24/bX

Device Class : 1

Duns Number: 071426803

Premarket Exempt : No

Product Code : JSJ

Prescription Use : No

Device Count : 24

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