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Onyx Liquid Embolic System液态栓塞系统

Brand EV3(医伟司安)
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 9775 Toledo Way, Irvine, CA 92618, United States of America
Intended Use The 0nyx-18, 0nyx-20, and 0nyx-34 series of products are used for embolization of peripheral and neurovascular injuries, including arterial malformations and vascular-rich tumors.0nyx-18,0nyx-20,0nyx-34系列产品用于外周和神经血管(包含动脉畸形和富含血管的肿瘤)损伤的栓塞。
References 105-7000-060, 105-7000-065, 105-7000-080
Manufacturer’s Website
Product Brochure
Registration Certificate 国械注进20173136690


These products are primarily composed of Ethylene-Vinyl Alcohol copolymer (EVOH), Dimethyl Sulfoxide solvent (DMSO), and embolic products made from micronized tantalum powder material. They are sterilized by high-temperature dry heat and are for single-use only. The embolic agent and the Dimethyl Sulfoxide solvent have a sterilization shelf life of 3 years. The product comes with an injector that is sterilized with ethylene oxide and is for single-use only. The injector has a sterilization shelf life of 3 years.


Risk-Based Classification风险管理类别

Product Status产品状态



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