SpiderFX Embolic Protection Device栓塞保护器

Brand	Medtronic（美敦力）
Manufacturer	ev3, Inc.医伟司安股份有限公司
Production Address	4600 Nathan Lane North, Plymouth, MN, 55442, United States
Intended Use	Used to provide distal embolic protection for patients during vascular intervention procedures, the use of vascular access includes peripheral vessels, coronary arteries, and carotid arteries.用于在血管介入手术中为患者提供尾端栓塞的保护，使用血管部位包括外周血管、冠状动脉和颈动脉。
References	SPD2-040-320, SPD2-050-320, SPD2-060-320 ………
Manufacturer’s Website	https://europe.medtronic.com/xd-en/healthcare-professionals/products/cardiovascular/embolic-protection-devices/spiderfx.html
Product Brochure
Registration Certificate	国械注进20173036163

Brand

This product consists of a capture net and SpiderFX guide wire, which is connected to a stainless steel wire. The capture net is made of a nickel-titanium alloy with an Applause heparin molecule coating covalently bonded to the alloy. The delivery end of the guide wire is flushed with a passive flushing needle during surgical preparation. The stainless steel wire is coated with a PTFE coating. The purpose of the heparin coating is to maintain the openness of the capture net. The product is sterilized with ethylene oxide and is for single use. The sterilization is effective for 2 years.

该产品由连接在不锈钢丝上的镍钛抓捕丝贯穿着的抓捕网和SpiderFX导管组成。抓捕网材料为镍钛合金，带有与镍钛合金共价结合的Applause肝素分子涂层。钝性冲洗针头在手术准备时用来冲洗导管的递送端。不锈钢丝外部涂覆PTFE涂层。肝素涂层目的在于保持抓捕网的开放。环氧乙烷灭菌，产品一次性使用。灭菌有效期2年。

Prodcuts List

REF	GTIN	Classification Code	Description
SPD2-060-320	00763000225179	03-13-23	SPD2-060-320 栓塞保护器
SPD2-050-190	00763000225148	03-13-23	SPD2-050-190 栓塞保护器
SPD2-030-320	00763000225117	03-13-23	SPD2-030-320 栓塞保护器
SPD2-050-320	00763000225155	03-13-23	SPD2-050-320 栓塞保护器
SPD2-040-320	00763000225131	03-13-23	SPD2-040-320 栓塞保护器
SPD2-060-190	00763000225162	03-13-23	SPD2-060-190 栓塞保护器

Risk-Based Classification风险管理类别	Class III （第三类）

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