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) (6) Light, Surgical, Floor Standing (FSS) (2) Device, Medical Examination, Ac Powered (KZF) (1) Lamp, Surgical (FTD) (1)

Premarket Exempt

Yes

Clear

ACEMSO15F - 08050705890408 Catalog Number : 110506

Device Description : ACEMSO15F 2-ARM CEILING STANDARD LINE

Device Class : 1

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : KZF

Prescription Use : Yes

Device Count : 1

STARLED3 NX - 08050705890415 Catalog Number : 110602

Device Description : STARLED3 NX WALL

Device Class : 2

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : FTD

Prescription Use : Yes

Device Count : 1

STARLED3 NX - 08050705890422 Catalog Number : 110603

Device Description : STARLED3 NX TROLLEY

Device Class : 2

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : FSS

Prescription Use : Yes

Device Count : 1

STARLED3 NX - 08050705890439 Catalog Number : 110604

Device Description : STARLED3 NX TROLLEY ABPS

Device Class : 2

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : FSS

Prescription Use : Yes

Device Count : 1

STARLED3 NX - 08050705890446 Catalog Number : 110605

Device Description : STARLED3 NX 1-ARM CEILING STANDARD LINE

Device Class : 2

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : Yes

Device Count : 1

STARLED3 NX - 08050705890453 Catalog Number : 110606

Device Description : STARLED3 NX 2-ARM CEILING STANDARD LINE w/OTHER DEVICE

Device Class : 2

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : Yes

Device Count : 1

STARLED3 NX - 08050705890460 Catalog Number : 110607

Device Description : STARLED3 NX 1-ARM CEILING MIDLINE

Device Class : 2

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : Yes

Device Count : 1

STARLED3 NX - 08050705890477 Catalog Number : 110608

Device Description : STARLED3 NX 2-ARM CEILING MIDLINE w/OTHER DEVICE

Device Class : 2

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : Yes

Device Count : 1

STARLED3 NX - 08050705890484 Catalog Number : 110610

Device Description : STARLED3 NX 2-ARM CEILING CENTRAL AXIS LINE w/OTHER DEVICE

Device Class : 2

Duns Number: 435188508

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : Yes

Device Count : 1

STARLED3 NX - 08050705890491 Catalog Number : 110611

Device Description : STARLED3 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

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