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InZone Detachment System & IZDS Connecting Cable可解脱弹簧圈分离系统
| Brand | Stryker（史赛克） |
|---|---|
| Manufacturer | Stryker Neurovascular史赛克神经介入 |
| Production Address | InZone分离系统 |
| 承产商：Benchmark Electronics Inc. | |
| 生产地址：4065 Theurer Boulevard Winona, MN 55987 USA | |
| IZDS 连接电缆 | |
| 承产商：Amphenol Alden Products Company. | |
| 生产地址：Ave.Severiano Talamante No.68 Colonia El Sahuaro Parque lndustrial Daynatech Hermosillo, Sonora CP 83170 Mexico | |
| Intended Use | Intended for embolization treatment of intracranial aneurysms and other vascular malformations of the nervous and peripheral vascular systems in conjunction with detachable coils (Target, GDC, and Matrix 2) from Stryker.旨在颅内动脉瘤以及神经和周围血管系统的其他血管畸形的栓塞治疗中与Stryker可分离式线圈（Target、GDC和Matrix 2）配合使用。 |
| References | M00345100950, M00345110250……… |
| Manufacturer’s Website | |
| Product Brochure | |
| Registration Certificate | 国械注进20143015660 |
Brand
The product consists of a power console (M00345100950), connecting cables (M00345110250), and two 1.5V batteries. The product is for single-use only and sterilized with ethylene oxide.
产品由电源主机（M00345100950）、连接线缆（M00345110250）及2节1.5V电池组成。产品为一次性使用，环氧乙烷灭菌。
| Risk-Based Classification风险管理类别 | |
|---|---|
| Product Status产品状态 | Active |
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