Liebel-Flarsheim Company LLC

Address:2111 EAST GALBRAITH RD.,Cincinnati,OH,45237,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

Injector And Syringe, Angiographic (DXT) (4) Injector, Contrast Medium, Automatic (IZQ) (3) Stand, Infusion (FOX) (3)

Premarket Exempt

No Yes

Clear

LF - 10746190004752 Catalog Number :

Device Description : Hand Button Start Switch (Accessory)

Device Class : 2

Duns Number: 080186051

Premarket Exempt : No

Product Code : IZQ

Prescription Use : No

Device Count : 1

LF - 10746190004769 Catalog Number :

Device Description : OptiStar Elite, Stand CPU (Accessory)

Device Class : 1

Duns Number: 080186051

Premarket Exempt : Yes

Product Code : FOX

Prescription Use : Yes

Device Count : 1

LF - 10746190004776 Catalog Number : 802850S

Device Description : OptiStar Elite, Fixed Height Stand Assembly (Accessory)

Device Class : 1

Duns Number: 080186051

Premarket Exempt : Yes

Product Code : FOX

Prescription Use : Yes

Device Count : 1

LF - 10746190004806 Catalog Number :

Device Description : OptiBolus, Bolus Shaping Software, Domestic (Accessory)

Device Class : 2

Duns Number: 080186051

Premarket Exempt : No

Product Code : IZQ

Prescription Use : No

Device Count : 1

LF - 10746190004813 Catalog Number :

Device Description : OptiBolus, Bolus Shaping Software, International (Accessory)

Device Class : 2

Duns Number: 080186051

Premarket Exempt : No

Product Code : IZQ

Prescription Use : No

Device Count : 1

LF - 10746190004820 Catalog Number :

Device Description : OptiVantage/OptiOne, Remote Stand (Accessory)

Device Class : 1

Duns Number: 080186051

Premarket Exempt : Yes

Product Code : FOX

Prescription Use : Yes

Device Count : 1

LF - 10746190004837 Catalog Number :

Device Description : Angiomat Illumena Foot Switch, Remote Start (Accessory)

Device Class : 2

Duns Number: 080186051

Premarket Exempt : No

Product Code : DXT

Prescription Use : No

Device Count : 1

LF - 10746190004844 Catalog Number :

Device Description : Angiomat Illumena Hand Button Start Switch (Accessory)

Device Class : 2

Duns Number: 080186051

Premarket Exempt : No

Product Code : DXT

Prescription Use : No

Device Count : 1

LF - 10746190004851 Catalog Number :

Device Description : Angiomat Illumena Hand Button Start Switch (Accessory)

Device Class : 2

Duns Number: 080186051

Premarket Exempt : No

Product Code : DXT

Prescription Use : No

Device Count : 1

LF - 10746190004868 Catalog Number :

Device Description : Angiomat Illumena Hand Button Start Switch (Accessory)

Device Class : 2

Duns Number: 080186051

Premarket Exempt : No

Product Code : DXT

Prescription Use : No

Device Count : 1

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