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SOFIA Distal Access Catheter远端通路导管
| Brand | MicroVention(美科微先) |
|---|---|
| Manufacturer | MicroVention, Inc.美科微先公司 |
| Production Address | 1. 1311 Valencia Ave. Tustin, CA 92780, USA；2. Zona Franca Coyol Alajuela Costa Rica3. 35 Enterprise, Aliso Viejo, CA 92656, USA |
| Intended Use | This product is suitable for general intravascular use, including neurovascular and peripheral vascular systems; it assists in the introduction of diagnostic or therapeutic devices; it is not suitable for coronary arteries.该产品适用于一般性血管内使用，包括神经血管和外周血管系统；有助于导入诊断性或治疗装置；不适用于冠状动脉。 |
| References | DA5125ST,DA6125ST…….. |
| Manufacturer’s Website | https://www.microvention.com/chapla/products/sofia |
| Product Brochure | |
| Registration Certificate | 国械注进20193030007 |
Brand
The product is a non-conical single-lumen catheter, with the catheter inner wall made of polytetrafluoroethylene and polyolefin, and the catheter body made of stainless steel coil and braided silk double-layer composite structure. The catheter outer wall material is polyurethane, PEBAX, and polyamide, with a hydrophilic coating on the outer surface. The distal end of some models has steam plasticity and non-radiopaque markers. The hydrophilic coating materials are Hydak B-23K and Hydak A-15. The packaging also includes an accessory introducer sheath, and some models come with a steam molding rod. Ethylene oxide sterilization, for single use. The shelf life is three years.
该产品是一种非锥形的单腔导管，导管内壁材料为聚四氟乙烯和聚烯烃，管身使用不锈钢线圈和编织丝双层复合结构，导管外壁材料为聚氨酯，PEBAX和聚酰胺，外表面带有亲水涂层。部分型号规格的远端具有蒸汽可塑性，并带有不透射线标记。亲水涂层材料为Hydak B-23K和Hydak A-15。包装内还有附件导入鞘管，部分型号规格配有蒸汽塑形杆。环氧乙烷灭菌，一次性使用。货架有效期三年。
Product List
| REF | GTIN | Classification Code | Description |
|---|---|---|---|
| DA5115ST | 00842429101421 | 03-13-02 | 远端通路导管 |
| DA5125ST | 00842429101438 | 03-13-02 | 远端通路导管 |
| DA6115ST | 00842429101445 | 03-13-02 | 远端通路导管 |
| DA6125ST | 00842429101452 | 03-13-02 | 远端通路导管 |
| DA6131ST | 00842429101469 | 03-13-02 | 远端通路导管 |
| DA6135ST | 00842429110713 | 03-13-02 | 远端通路导管 |
| Risk-Based Classification风险管理类别 | |
|---|---|
| Product Status产品状态 | Active |
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