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

Table, Cystometric, Non-Electric And Accessories (KQS) (5) Stand, Infusion (FOX) (3) Injector, Contrast Medium, Automatic (IZQ) (2)

Premarket Exempt

No Yes

Clear

LF - 10746190004608 Catalog Number :

Device Description : Hydra Vision Digital Imaging System, Leg Crutch Adult Pad and Post, Pair (Accessory)

Device Class : 1

Duns Number: 080186051

Premarket Exempt : Yes

Product Code : KQS

Prescription Use : Yes

Device Count : 1

LF - 10746190004615 Catalog Number :

Device Description : Hydra Vision Digital Imaging System, Restraint Strap (Non-Conductive) (Accessory)

Device Class : 1

Duns Number: 080186051

Premarket Exempt : Yes

Product Code : KQS

Prescription Use : Yes

Device Count : 1

LF - 10746190004639 Catalog Number :

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

Device Class : 1

Duns Number: 080186051

Premarket Exempt : Yes

Product Code : KQS

Prescription Use : Yes

Device Count : 1

LF - 10746190004660 Catalog Number :

Device Description : Hydra Vision Digital Imaging System, Elbow Rests, Pair (Accessory)

Device Class : 1

Duns Number: 080186051

Premarket Exempt : Yes

Product Code : KQS

Prescription Use : Yes

Device Count : 1

LF - 10746190004684 Catalog Number :

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

Device Class : 1

Duns Number: 080186051

Premarket Exempt : Yes

Product Code : KQS

Prescription Use : Yes

Device Count : 1

LF - 10746190004707 Catalog Number :

Device Description : Illumena, Remote Stand (Accessory)

Device Class : 1

Duns Number: 080186051

Premarket Exempt : Yes

Product Code : FOX

Prescription Use : Yes

Device Count : 1

LF - 10746190004714 Catalog Number :

Device Description : Heater Blanket (Accessory)

Device Class : 2

Duns Number: 080186051

Premarket Exempt : No

Product Code : IZQ

Prescription Use : No

Device Count : 1

LF - 10746190004721 Catalog Number :

Device Description : OptiStar Elite, Mobile Mount Console Bracket

Device Class : 1

Duns Number: 080186051

Premarket Exempt : Yes

Product Code : FOX

Prescription Use : Yes

Device Count : 1

LF - 10746190004738 Catalog Number :

Device Description : OptiStar Elite, Power Supply Wall Mount (Accessory)

Device Class : 1

Duns Number: 080186051

Premarket Exempt : Yes

Product Code : FOX

Prescription Use : Yes

Device Count : 1

LF - 10746190004745 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

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