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

Punch, Biopsy, Surgical (EME) (4) Apparatus, Exhaust, Surgical (FYD) (3) Powered Laser Surgical Instrument (GEX) (3)

Premarket Exempt

No Yes

Clear

ACU-EVAC - 00814105020562 Catalog Number :

Device Description : Cart for mounting of Evac unit that provides portability and convenience. Unit Cart for mounting of Evac unit that provides portability and convenience. Unit has four wheels two of which swivel

Device Class : 2

Duns Number: 071426803

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

ACU-EVAC - 00814105020579 Catalog Number :

Device Description : Cart bracket for mounting of a Hyfrecator or other electrosurgical unit to an Ev Cart bracket for mounting of a Hyfrecator or other electrosurgical unit to an Evac cart, above the smoke evacuator

Device Class : 2

Duns Number: 071426803

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

ACU-EVAC - 00814105020586 Catalog Number :

Device Description : Rubber feet Acu-Evac 1E or Acu-Evac II when mounting on a tabletop or countertop

Device Class : 2

Duns Number: 071426803

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

ACU-GUARD - 00814105020852 Catalog Number :

Device Description : Acu-Guard II easy fit disposable clear sheaths non-sterile

Device Class : 2

Duns Number: 071426803

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

ACU-GUARD - 00814105020869 Catalog Number :

Device Description : Acu-Guard II easy fit disposable clear sheaths non-sterile

Device Class : 2

Duns Number: 071426803

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

ACU-GUARD - 00814105020876 Catalog Number :

Device Description : Acu-Guard II easy fit disposable clear sheaths sterile

Device Class : 2

Duns Number: 071426803

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Acu-Punch - 00814105020883 Catalog Number :

Device Description : Acu-Punch, 1mm, 1ea

Device Class :

Duns Number: 071426803

Premarket Exempt : Yes

Product Code : EME

Prescription Use : No

Device Count : 1

Acu-Punch - 00814105020890 Catalog Number :

Device Description : Acu-Punch, 1.5mm, Single

Device Class :

Duns Number: 071426803

Premarket Exempt : Yes

Product Code : EME

Prescription Use : No

Device Count : 1

Acu-Punch - 00814105020906 Catalog Number :

Device Description : Acu-Punch, 2mm, Single

Device Class :

Duns Number: 071426803

Premarket Exempt : Yes

Product Code : EME

Prescription Use : No

Device Count : 1

Acu-Punch - 00814105020913 Catalog Number :

Device Description : Acu-Punch, 2.5mm, Single

Device Class :

Duns Number: 071426803

Premarket Exempt : Yes

Product Code : EME

Prescription Use : No

Device Count : 1

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