PRAXIS MEDICAL LLC

Address:500 N WILLOW AVE STE 101,Tampa,FL,33606,US

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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

Instrument, Biopsy (KNW) (2)

Premarket Exempt

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Praxis Medical - 00860003935804 Catalog Number :

Device Description : The Praxis Medical CytoCore is a syringe-holding device for performing a biopsy The Praxis Medical CytoCore is a syringe-holding device for performing a biopsy of soft tissue for diagnostic sampling. It is equipped with a scissor-slide mechanism for drawing back the syringe plunger to create suction, and an internal motor which rotates the needle clockwise and counterclockwise motion to facilitate cellular material harvesting. The device places the hand relatively close to the needle tip while the hand is in a position of natural function, providing greater tactile sensation of the texture of the lesion and enabling accurate needle placement using fine motor control of the hand. The device enables an operator to place a needle into a target area to harvest cells.

Device Class :

Duns Number: 939493362

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

Praxis Medical CytoCore and CytoCore Luer Adapters - 00860003935866 Catalog Number :

Device Description : CytoCore device (DI 00860003935804) with extra luer adapters pouch (DI 00860003935835)

Device Class :

Duns Number: 939493362

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 5

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