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

Light, Surgical, Ceiling Mounted (FSY) (8) Light, Surgical, Floor Standing (FSS) (1)

Premarket Exempt

Yes

Clear

STARLED5 NX - 08050705890507 Catalog Number : 110703

Device Description : STARLED5 NX TROLLEY

Device Class : 2

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : FSS

Prescription Use : Yes

Device Count : 1

STARLED5 NX - 08050705890514 Catalog Number : 110707

Device Description : STARLED5 NX 1-ARM CEILING MIDLINE

Device Class : 2

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : Yes

Device Count : 1

STARLED5 NX - 08050705890521 Catalog Number : 110708

Device Description : STARLED5 NX 2-ARM CEILING MIDLINE

Device Class : 2

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : Yes

Device Count : 1

STARLED5 NX - 08050705890538 Catalog Number : 110709

Device Description : STARLED5 NX 1-ARM CEILING CENTRAL AXIS

Device Class : 2

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : Yes

Device Count : 1

STARLED5 NX - 08050705890545 Catalog Number : 110710

Device Description : STARLED5 NX 2-ARM CEILING CENTRAL AXIS LINE w/OTHER DEVICES

Device Class : 2

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : Yes

Device Count : 1

STARLED5 NX - 08050705890552 Catalog Number : 110711

Device Description : STARLED5 NX 3-ARM CEILING CENTRAL AXIS LINE w/OTHER DEVICES

Device Class : 2

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : Yes

Device Count : 1

STARLED5 NX - 08050705890569 Catalog Number : 110713

Device Description : STARLED5 NX 1-ARM CEILING MODULAR LINE

Device Class : 2

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : Yes

Device Count : 1

STARLED5 NX - 08050705890576 Catalog Number : 110714

Device Description : STARLED5 NX 2-ARM CEILING MODULAR LINE w/OTHER DEVICE

Device Class : 2

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : Yes

Device Count : 1

STARLED5 NX - 08050705890583 Catalog Number : 110715

Device Description : STARLED5 NX 3-ARM CEILING MODULAR LINE w/OTHER DEVICES

Device Class : 2

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : Yes

Device Count : 1

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