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Name

Rebar Micro Catheter微导管

Brand Medtronic(美敦力)
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 4600 Nathan Lane North, Plymouth, MN, 55442, United States
Intended Use This product is used for the infusion of special treatment products and contrast agents into peripheral and neurovascular vessels under the control and selection of professional doctors.该产品用于专业医生控制和选择特殊治疗产品的灌注,以及造影剂的灌注到外周及神经血管。
References 105-5078-153C,105-5080-153C,105-5081-130,105-5081-153,105-5083-153,105-5082-130,105-5082-145
Manufacturer’s Website
Product Brochure
Registration Certificate 国械注进20183031711

Brand

The product is a single-lumen microcatheter with a guidewire. The catheter body is made of polyetheramide polymer material with a 304V stainless steel support coil, lined with polytetrafluoroethylene, and coated with hyaluronic acid on the outer surface of the catheter. The hub material is polypropylene. The distal end of the catheter has one or two platinum/iridium alloy radiopaque markers. It is sterilized with ethylene oxide and is for single use. The shelf life is 2 years.

该产品为过导丝型单腔微导管,包装内带有一个蒸汽塑形针。导管管体由带有304V不锈钢支撑线圈的聚醚酰胺聚合物材料制成,内衬聚四氟乙烯,管体外表面涂有透明质酸涂层;座的材料为聚丙烯;导管远端上有一个或两个铂/铱合金不透射线标记。环氧乙烷灭菌,一次性使用。货架有效期2年。

Risk-Based Classification风险管理类别

Product Status产品状态

Active

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