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Name

ASAHI SION导丝

Brand ASAHI(朝日)
Manufacturer ASAHI INTECC CO.,LTD.日本朝日英达科株式会社
Production Address 日本生产地址: 爱知果濒尸市晚IIIJ 3番地100C 3-100, Akatsuki-Cho, Seto, Aichi 489-0071 Japan)
泰国生产地址: 158/1 Moo5 Bangkadi Industrial Park, Tiwanon Road, Tambol Bangkadi Amphur Muang, Pathumthani 12000, Thailand
越南生产地址: Thang Long Industrial Park, Dong Anh District, Hanoi, Vietnam
Intended Use Applicable for percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) for intravascular diagnosis or intervention.适用于经皮腔内冠状动脉成形术(PTCA)和经皮腔内血管成形术(PTA)中导引血管内诊断或介入器械。
References AHW14R001S、AHW14R301S ………
Manufacturer’s Website https://medical.asahi-intecc.com/en/products-coronary/asahi-sion.html
Product Brochure
Registration Certificate 国械注进20183031886

Brand

The product consists of a guidewire, a tapered core wire, and a safety wire. The guidewire is composed of an outer wire and an inner wire, with the outer wire consisting of a distal platinum-nickel alloy radiopaque wire and a proximal SUS316 stainless steel wire; the material of the inner wire is SUS316 stainless steel. The material of the safety wire is SUS316 stainless steel. The proximal core wire is coated with a polytetrafluoroethylene (PTFE) coating, and the entire guidewire surface is covered with a hydrophilic coating (polyethylene pyrrolidone, nitrocellulose, and polyurethane). Ethylene oxide sterilization, single-use, with a shelf life of two years and eleven months.

产品由绕丝、锥形芯丝和安全丝构成。绕丝由外部绕丝和内部绕丝组成,其中外部绕丝分为远端铂镍合金不透射线绕丝和近端SUS316不锈钢绕丝;内部绕丝的材料为SUS316不锈钢。安全丝的材料为SUS316不锈钢。近端芯丝表面涂覆有聚四氟乙烯涂层,整个绕丝表面覆有亲水涂层(聚乙烯吡咯烷酮、硝酸纤维素和聚亚安酯)。环氧乙烷灭菌,一次性使用,货架有效期两年十一个月。

Risk-Based Classification风险管理类别

Product Status产品状态

Active

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