| 注册证编号 | 苏械注准20222032046 [查看相关产品信息] |
| 注册人名称 | 苏州恒瑞迪生医疗科技有限公司[查看公司信息] |
| 注册人住所 | 苏州市锦峰路8号11号楼南一楼 |
| 生产地址 | 苏州高新区锦峰路8号11号楼南一楼 |
| 产品名称 | 导引鞘组 |
| 管理类别 | 第二类 |
| 型号规格 | GS-4-45-0-HC、GS-4-45-1-HC、GS-4-45-2-HC、GS-4-45-3-HC、GS-4-55-0-HC、GS-4-55-1-HC、GS-4-55-2-HC、GS-4-55-3-HC、GS-4-70-0-HC、GS-4-70-1-HC、GS-4-70-2-HC、GS-4-70-3-HC、GS-4-90-0-HC、GS-4-90-1-HC、GS-4-90-2-HC、GS-4-90-3-HC、GS-4-110-0-HC、GS-4-110-1-HC、GS-4-110-2-HC、GS-4-110-3-HC、GS-5-45-0-HC、GS-5-45-1-HC、GS-5-45-2-HC、GS-5-45-3-HC、GS-5-55-0-HC、GS-5-55-1-HC、GS-5-55-2-HC、GS-5-55-3-HC、GS-5-70-0-HC、GS-5-70-1-HC、GS-5-70-2-HC、GS-5-70-3-HC、GS-5-90-0-HC、GS-5-90-1-HC、GS-5-90-2-HC、GS-5-90-3-HC、GS-5-110-0-HC、GS-5-110-1-HC、GS-5-110-2-HC、GS-5-110-3-HC、GS-6-40-4-HC、GS-6-45-0-HC、GS-6-45-1-HC、GS-6-45-2-HC、GS-6-45-3-HC、GS-6-55-0-HC、GS-6-55-1-HC、GS-6-55-2-HC、GS-6-55-3-HC、GS-6-70-0-HC、GS-6-70-1-HC、GS-6-70-2-HC、GS-6-70-3-HC、GS-6-90-0-HC、GS-6-90-1-HC、GS-6-90-2-HC、GS-6-90-3-HC、GS-7-40-4-HC、GS-7-45-0-HC、GS-7-45-1-HC、GS-7-45-2-HC、GS-7-45-3-HC、GS-7-55-0-HC、GS-7-55-1-HC、GS-7-55-2-HC、GS-7-55-3-HC、GS-7-70-0-HC、GS-7-70-1-HC、GS-7-70-2-HC、GS-7-70-3-HC、GS-7-90-0-HC、GS-7-90-1-HC、GS-7-90-2-HC、GS-7-90-3-HC、GS-8-40-4-HC、GS-8-45-0-HC、GS-8-45-1-HC、GS-8-45-2-HC、GS-8-45-3-HC、GS-8-55-0-HC、GS-8-55-1-HC、GS-8-55-2-HC、GS-8-55-3-HC、GS-8-70-0-HC、GS-8-70-1-HC、GS-8-70-2-HC、GS-8-90-0-HC、GS-8-90-1-HC、GS-8-90-2-HC、GS-8-90-3-HC、GS-8-70-3-HC |
| 结构及组成/主要组成成分 | 导引鞘组由导引鞘和扩张器2个部件组成。导引鞘由显影环、鞘管、亲水涂层、应力扩散管、鞘座、止血垫、鞘座盖、侧支、三通阀、三通保护帽组成。扩张器由扩张器管体、扩张器座组成。产品以无菌状态提供，经环氧乙烷灭菌，一次性使用。 |
| 适用范围/预期用途 | 预期用于将治疗和诊断器械导入血管系统，不适用于冠状动脉和神经血管。 |
| 审批部门 | 江苏省药品监督管理局 |
| 批准日期 | 2022/11/25 |
| 生效日期 | 2022/11/25 |
| 有效期至 | 2027/11/24 |
