Home GUDID 00860003935804
Praxis Medical
Primary DI 00860003935804
Brand Praxis Medical
Company PRAXIS MEDICAL LLC
Model C0025
Device description 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.
Published 2020-08-07
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name KNW Instrument, Biopsy
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KNW Instrument, Biopsy Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860003935811 Package GS1 5 In Commercial Distribution 00860003935828 Package GS1 18 In Commercial Distribution 00860003935804 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860003935811 00860003935811 860003935811 0860003935811 00860003935828 00860003935828 860003935828 0860003935828 00860003935804 00860003935804 860003935804 0860003935804
GMDN Terms# Term, Definition table Term Definition Biopsy syringe holder, reusable A hand-operated device designed to hold a biopsy syringe to facilitate precision aspiration of a tissue specimen through a biopsy needle. The holder is typically made of metal and plastic materials and typically designed as a lightweight, hand-held frame in which the syringe is placed and its piston withdrawn using a sliding handle in the frame; a stopper may be included to prevent further aspiration at a predetermined point. This is a reusable device.
Regulatory Flags# DUNS number 939493362 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00841911103776 Mammotome Prima DEVICOR MEDICAL PRODUCTS, INC. KNW 2026-06-09 08800025901151 BEXCORE Breast Biopsy System MedicalPark CO.,LTD. KNW 2026-06-01 08800025902059 BEXCORE Breast Biopsy System MedicalPark CO.,LTD. KNW 2026-06-01 06937278635983 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278635990 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636003 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636010 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636027 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636034 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636041 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636058 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636065 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636072 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636089 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636096 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636102 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636119 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636126 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636133 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636140 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636157 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636164 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636171 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636188 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636195 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636201 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636218 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636225 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636232 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31 06937278636249 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-05-31