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Name

Traxcess Guidewires导丝

Brand MicroVention(美科微先)
Manufacturer MicroVention, Inc.美科微先公司
Production Address 35 Enterprise, Aliso Viejo, CA 92656, USA; 150 Maimaigi-cho Fujinomiya-shi Shizuoka, 418-0015 Japan.
Intended Use This product is suitable for general vascular use, including the neurovascular system and peripheral vascular system. The guidewire can be used with diagnostic or therapeutic catheters to place them at the desired lesion site. This device is not intended for use in coronary arteries.该产品适用于一般性血管内用途,包括神经血管系统和外周血管系统。导丝可配合诊断或治疗用导管使用,以便将其放置到所选择的病变位置。此器械不适用于冠状动脉。
References GW1420040 ………
Manufacturer’s Website https://www.microvention.com/chapla/products/traxcess
Product Brochure
Registration Certificate 国械注进20153031033

Brand

The product consists of a guidewire, guidewire extension, and accessories. The accessories include a shaping mandrel, torque device, and insertion tool. The guidewire is divided into non-extendable and extendable types, composed of a core wire and coil wire. The distal core wire is made of nitinol alloy, while the proximal core wire is made of 304 stainless steel and coated with a polytetrafluoroethylene layer. The coil wire is divided into two segments, with the distal segment made of nitinol alloy and the proximal segment made of 304 stainless steel, coated with a hydrophilic coating. The connection of the extension piece is made of nitinol alloy, while the body is made of 304 stainless steel and coated with a polytetrafluoroethylene layer. It is sterilized with ethylene oxide and intended for single-use. The shelf life is three years.

该产品由导丝、导丝延长件和附件组成,附件包括成形杆、扭矩装置和插入工具。导丝分为不可延长导丝和可延长导丝,由芯丝、绕丝组成;远段芯丝由镍钛合金制成,近段芯丝由304不锈钢制成,芯丝涂有聚四氟乙烯涂层;绕丝分为两段,远段由镍钛合金制成,近段由304不锈钢制成,绕丝涂有亲水涂层。延长件的连接处由镍钛合金制成,件体由304不锈钢制成,涂有聚四氟乙烯涂层。环氧乙烷灭菌,一次性使用。货架有效期三年。

Product List

REFGTINClassification CodeDescription
GW142004081017001228003-13-16导丝
GW14100EX81017001487103-13-16导丝
GW1420040X81017001486403-13-16导丝
Risk-Based Classification风险管理类别

Product Status产品状态

Active

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