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	https://europe.medtronic.com/xd-en/healthcare-professionals/products/neurological/avm-embolization/onyx-liquid-embolic.html
Product Brochure
Registration Certificate	国械注进20173136690

Brand

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.

该产品主要成分为乙烯-乙烯醇聚合物（EVOH）、二甲基亚砜溶剂（DMSO）和微粉化钽粉材料制成的栓塞产品。经高温干热灭菌，一次性使用。栓塞剂和二甲基亚砜溶剂灭菌有效期3年。该产品配有注射器。注射器经环氧乙烷灭菌。一次性使用。注射器灭菌有效期3年

Risk-Based Classification风险管理类别	Class III （第三类）
Product Status产品状态	Active

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