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Name

Navien Intracranial Support Catheter颅内支撑导管

Brand EV3(医伟司安)
Manufacturer Micro Therapeutics, Inc.DBA ev3 Neurovascular麦克罗医伟司安神经血管医疗股份有限公司
Production Address 9775 Toledo Way Irvine, CA, 92618 USA
Intended Use This product is used for delivering interventional devices in the peripheral and neurovascular systems.该产品用于在外周和神经血管里输送介入器材。
References RFX072-115-08MP, RFX058-115-08 ……
Manufacturer’s Website
Product Brochure
Registration Certificate 国械注进20143036248

Brand

The product is a single lumen, flexible catheter made of composite materials with different hardness. The catheter shaft is coated with a hydrophilic coating and reinforced with a nitinol coil layer for X-ray visibility. The inner lumen of the catheter can accommodate guide wires with a diameter of up to 0.038 inches to assist with catheter system placement; it is lined with PTFE. The distal end of the catheter has a platinum radiopaque marker band, and the proximal end has a Luer connector for connecting accessories and injecting fluids through the system. It is sterilized with ethylene oxide, for single-use only, with a shelf life of 2 years.

该产品是一根单腔、有弹性的、由不同硬度的复合材料制成的导管。导管管身带有亲水性涂层;管身使用镍钛合金线圈层加强;可在X线透视下显影。导管内腔可容纳直径不超过0.038英寸的导丝,以辅助导管系统的到位;内衬为PTFE。导管远端有铂金不透射线的标记带;近端带有鲁尔接头,可连接配件和通过该系统注射液体。环氧乙烷灭菌,一次性使用,货架有效期2年。

Product List

REFGTINClassification CodeDescription
RFX058-105-080084753601774003-13-02RFX058-105-08 颅内支撑导管
RFX058-115-080084388904795303-13-02RFX058-115-08 颅内支撑导管
RFX058-115-080084753601779503-13-02RFX058-115-08 颅内支撑导管
RFX058-125-080084388904797703-13-02RFX058-125-08 颅内支撑导管
RFX058-125-080084753601784903-13-02RFX058-125-08 颅内支撑导管
RFX058-130-080084753601789403-13-02RFX058-130-08 颅内支撑导管
RFX058-130-080084388904799103-13-02RFX058-130-08 颅内支撑导管
RFX072-105-080084753601786303-13-02RFX072-105-08 颅内支撑导管
RFX072-105-08MP0084753601788703-13-02RFX072-105-08MP 颅内支撑导管
RFX072-105-08MP0084388904802803-13-02RFX072-105-08MP 颅内支撑导管
RFX072-115-080084753601790003-13-02RFX072-115-08 颅内支撑导管
RFX072-115-08MP0084753601792403-13-02RFX072-115-08MP 颅内支撑导管
RFX072-115-08MP0084388904805903-13-02RFX072-115-08MP 颅内支撑导管
RFX072-125-080084753601794803-13-02RFX072-125-08 颅内支撑导管
RFX072-125-08MP0084753601796203-13-02RFX072-125-08MP 颅内支撑导管
RFX072-130-080084753601798603-13-02RFX072-130-08 颅内支撑导管
RFX072-130-08MP0084753601800603-13-02RFX072-130-08MP 颅内支撑导管
RFX072-95-080084753601802003-13-02RFX072-95-08 颅内支撑导管
RFX072-95-08MP0084753601804403-13-02RFX072-95-08MP 颅内支撑导管
Risk-Based Classification风险管理类别

Product Status产品状态

Inactive

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