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, Contrast Medium, Automatic (IZQ) (5) Table, Cystometric, Non-Electric And Accessories (KQS) (5)

Premarket Exempt

No Yes

Clear

LF - 10746190004325 Catalog Number :

Device Description : OptiOne Single-Head CT Contrast Delivery System

Device Class : 2

Duns Number: 080186051

Premarket Exempt : No

Product Code : IZQ

Prescription Use : Yes

Device Count : 1

LF - 10746190004332 Catalog Number :

Device Description : OptiVantage Dual-Head CT Contrast Delivery System, Simultaneous Injection, OEM Interface

Device Class : 2

Duns Number: 080186051

Premarket Exempt : No

Product Code : IZQ

Prescription Use : Yes

Device Count : 1

LF - 10746190004349 Catalog Number :

Device Description : OptiVantage Dual-Head CT Contrast Delivery System, Simultaneous Injection, OEM Interface

Device Class : 2

Duns Number: 080186051

Premarket Exempt : No

Product Code : IZQ

Prescription Use : Yes

Device Count : 1

LF - 10746190004356 Catalog Number :

Device Description : OptiVantage Dual-Head CT Contrast Delivery System, OEM Interface

Device Class : 2

Duns Number: 080186051

Premarket Exempt : No

Product Code : IZQ

Prescription Use : Yes

Device Count : 1

LF - 10746190004363 Catalog Number :

Device Description : OptiVantage Dual-Head CT Contrast Delivery System, OEM Interface

Device Class : 2

Duns Number: 080186051

Premarket Exempt : No

Product Code : IZQ

Prescription Use : Yes

Device Count : 1

LF - 10746190004516 Catalog Number :

Device Description : Hydra Vision Digital Imaging System, Hand Grip Assembly, Pair (Accessory)

Device Class : 1

Duns Number: 080186051

Premarket Exempt : Yes

Product Code : KQS

Prescription Use : Yes

Device Count : 1

LF - 10746190004523 Catalog Number :

Device Description : Hydra Vision Digital Imaging System, Footstep Assembly (Accessory)

Device Class : 1

Duns Number: 080186051

Premarket Exempt : Yes

Product Code : KQS

Prescription Use : Yes

Device Count : 1

LF - 10746190004530 Catalog Number :

Device Description : Hydra Vision Digital Imaging System, Uro Drain Assembly (Accessory)

Device Class : 1

Duns Number: 080186051

Premarket Exempt : Yes

Product Code : KQS

Prescription Use : Yes

Device Count : 1

LF - 10746190004547 Catalog Number :

Device Description : Hydra Vision Digital Imaging System, Armboard (Accessory)

Device Class : 1

Duns Number: 080186051

Premarket Exempt : Yes

Product Code : KQS

Prescription Use : Yes

Device Count : 1

LF - 10746190004554 Catalog Number :

Device Description : Hydra Vision Digital Imaging System, Foot Extension (Accessory)

Device Class : 1

Duns Number: 080186051

Premarket Exempt : Yes

Product Code : KQS

Prescription Use : Yes

Device Count : 1

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