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materials and typically designed as a lightweight, hand-held frame in which the syringe is placed and its piston withdrawn using a sliding handle in the frame; a stopper may be included to prevent further aspiration at a predetermined point.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 00810131882983 BMAN BCOR Bone Marrow Aspirate Kit Surgentec, LLC KNW 2026-08-19 00810131884697 BMAN BCOR Bone Marrow Aspirate Kit (with Clip) Surgentec, LLC KNW 2026-08-19 00884450476079 CorVocet™ Merit Medical Systems, Inc. KNW 2026-08-18 00884450476093 CorVocet™ Merit Medical Systems, Inc. KNW 2026-08-18 06937278634917 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278634924 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278634931 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278634962 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278634979 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278634986 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635013 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635020 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635037 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635068 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635075 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635082 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635112 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635129 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635136 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635167 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635174 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635181 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635211 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635228 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635235 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635266 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635273 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635280 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635310 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15 06937278635327 Curaway Zhejiang CuraWay Medical Technology Co., Ltd. KNW 2026-08-15