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Fielder XT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：愛知県瀬戸巿暁町3番地100;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 | The guidewire is used to assist in the positioning of the balloon dilation catheter during percutaneous transluminal coronary angioplasty (PTCA) procedures.导丝适用于经皮腔内冠状动脉成形术(PTCA)过程中辅助球囊扩张导管的位置。 |
| References | AGP140002， AGP140302 ，AGP140001、AGP140001J、AGP140301、AGP140301J ……… |
| Manufacturer’s Website | https://medical.asahi-intecc.com/en/products-coronary/fielder-xt.html |
| Product Brochure | |
| Registration Certificate | 国械注进20183031885 |
Brand
The product consists of a tapered core wire (made of SUS304 stainless steel) and a coil wire. The stainless steel coil wire is made of austenitic stainless steel (SUS316) material, and the radiopaque coil wire is made of platinum-nickel alloy. The proximal surface of the tapered core wire is coated with polytetrafluoroethylene (PTFE), while the distal end is coated with a hydrophilic polymer. It is sterilized with ethylene oxide and is for single-use only. The shelf life is 36 months.
产品由锥形芯丝（SUS304不锈钢）和绕丝组成。不锈钢绕丝由奥氏体不锈钢（SUS316）材料制成，不透射线绕丝由铂镍合金制成。锥形芯丝的近端表面覆有聚四氟乙烯涂层，远端覆有亲水性聚合物涂层。环氧乙烷灭菌，一次性使用，货架有效期36个月。
| Risk-Based Classification风险管理类别 | |
|---|---|
| Product Status产品状态 | Active |
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