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Name

ENTERPRISE Vascular Reconstruction Device and Deliver血管重建装置和传送系统

Brand CERENOVUS
Manufacturer Medos International SARL迈道国际有限公司
Production Address 340 Lake Hazeltine Dr., Chaska, MN 55318, USA
Intended Use This product is used together with the embolic device for the treatment of intracranial aneurysms.该产品与治疗颅内动脉瘤的栓塞装置一起使用。
References ENC452212,ENC452812 ……
Manufacturer’s Website https://www.jnjmedtech.com/en-US/product/enterprise-2-vascular-reconstruction-device
Product Brochure
Registration Certificate 国械注进20173130352

Brand

This product consists of a stent and a conveying system, where the conveying system includes a conveying wire and an inserter. The bracket is pre-installed on the conveying wire inside the inserter. The bracket is made of nickel-titanium alloy material and designed in a closed form. There are four tantalum markers at each end of the bracket, and the outer surface of the bracket is coated with a layer of polymer. The conveying wire is composed of a nickel-titanium alloy wire core with X-ray opaque markers. It is sterilized with ethylene oxide, for one-time use, and has a shelf life of two years.

该产品由支架和传送系统组成,传送系统包括一条传送导丝和一个导入器。支架预先安装在导入器内部的传送导丝上。支架由镍钛合金材料制成,采用闭合式设计。支架每一端有四个钽标记带,支架外表面涂有一层聚合物。传送导丝由带有不透X线标记的镍钛锘导丝芯构成。环氧乙烷灭菌,一次性使用,有效期二年。

Product List

REFGTINClassification CodeDescription
ENC4514001088670407146413-06-06血管重建装置和传送系统 ENC451400
ENC4514121088670404397313-06-06血管重建装置和传送系统 ENC451412
ENC4522001088670407147113-06-06血管重建装置和传送系统 ENC452200
ENC4522121088670404398013-06-06血管重建装置和传送系统 ENC452212
ENC4528001088670407148813-06-06血管重建装置和传送系统 ENC452800
ENC4528121088670404399713-06-06血管重建装置和传送系统 ENC452812
ENC4537001088670407149513-06-06血管重建装置和传送系统 ENC453700
ENC4537121088670404400013-06-06血管重建装置和传送系统 ENC453712
Risk-Based Classification风险管理类别

Product Status产品状态

Active

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