ACEM SPA

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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

Device, Medical Examination, Ac Powered (KZF) (10)

Premarket Exempt

Yes

Clear

ACEMST1 - 08050705890101 Catalog Number : 111000

Device Description : ACEMST1.3 ARTICULATED ARM RAIL

Device Class : 1

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : KZF

Prescription Use : Yes

Device Count : 1

ACEMST1 - 08050705890118 Catalog Number : 111001

Device Description : ACEMST1.3 ARTICULATED ARM TABLE

Device Class : 1

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : KZF

Prescription Use : Yes

Device Count : 1

ACEMST1 - 08050705890125 Catalog Number : 111002

Device Description : ACEMST1.3 ARTICULATED ARM WALL

Device Class : 1

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : KZF

Prescription Use : Yes

Device Count : 1

ACEMST1 - 08050705890132 Catalog Number : 111003

Device Description : ACEMST1.3 ARTICULATED ARM TROLLEY

Device Class : 1

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : KZF

Prescription Use : Yes

Device Count : 1

ACEMST1 - 08050705890149 Catalog Number : 111004

Device Description : ACEMST1.3 ARTICULATED ARM w/BATTERY TROLLEY

Device Class : 1

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : KZF

Prescription Use : Yes

Device Count : 1

ACEMST1 - 08050705890156 Catalog Number : 111005

Device Description : ACEMST1.3 ARTICULATED ARM CEILING

Device Class : 1

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : KZF

Prescription Use : Yes

Device Count : 1

ACEMST1 - 08050705890163 Catalog Number : 110900

Device Description : ACEMST1.1 FLEXIBLE ARM RAIL

Device Class : 1

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : KZF

Prescription Use : Yes

Device Count : 1

ACEMST1 - 08050705890170 Catalog Number : 110901

Device Description : ACEMST1.1 FLEXIBLE ARM TABLE

Device Class : 1

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : KZF

Prescription Use : Yes

Device Count : 1

ACEMST1 - 08050705890187 Catalog Number : 110902

Device Description : ACEMST1.1 FLEXIBLE ARM WALL

Device Class : 1

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : KZF

Prescription Use : Yes

Device Count : 1

ACEMST1 - 08050705890194 Catalog Number : 110903

Device Description : ACEMST1.1 FLEXIBLE ARM TROLLEY

Device Class : 1

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : KZF

Prescription Use : Yes

Device Count : 1

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