| 器械名称 | 髓腔铰刀 |
|---|---|
| 备案号 | 沪嘉械备20210095号 |
| 备案人名称 | 上海博进电子仪表设备工贸有限公司 |
| 企业联系电话 | 暂无权限 |
| 备案人注册地址 | 上海市嘉定区工业区回城南路1128号B322、B323 |
| 生产地址 | 上海市嘉定区马陆镇龙盘路125号215室 |
| 型号规格 | BJJDR-6.0-22.5-350-D,BJJDR-6.5-22.5-350-D,BJJDR-7.0-22.5-350-D,BJJDR-7.5-22.5-350-D,BJJDR-8.0-22.5-350-D,BJJDR-8.5-22.5-350-D,BJJDR-9.0-22.5-350-D,BJJDR-9.5-22.5-350-D,BJJDR-10.0-22.5-350-D,BJJDR-10.5-22.5-350-D,BJJDR-11.0-22.5-350-D,BJJDY-7.0-22-470-B,BJJDY-7.2-22-470-B,BJJDY-7.5-22-470-B,BJJDY-8.5-22-470-B,BJJDY-9.0-22-470-B,BJJDY-9.5-22-470-B,BJJDY-10.0-22-470-B,BJJDY-10.5-22-470-B,BJJDY-11.0-22-470-B,BJJDY-11.5-22-470-B,BJJDY-12.0-22-470-B,BJJDY-12.5-22-470-B,BJJDY-13.0-22-470-B,BJJDY-13.5-22-470-B,BJJDY-14.0-22-470-B,BJJDY-14.5-22-470-B,BJJDY-15.0-22-470-B,BJJDY-15.5-22-470-B,BJJDY-16.0-22-470-B,BJJDY-16.5-22-470-B,BJJDY-17.5-22-470-B,BJJDY-7.0-22-470-D,BJJDY-7.2-22-470-D,BJJDY-7.5-22-470-D,BJJDY-8.5-22-470-D,BJJDY-9.0-22-470-D,BJJDY-9.5-22-470-D,BJJDY-10.0-22-470-D,BJJDY-10.5-22-470-D,BJJDY-11.0-22-470-D,BJJDY-11.5-22-470-D,BJJDY-12.0-22-470-D,BJJDY-12.5-22-470-D,BJJDY-13.0-22-470-D,BJJDY-13.5-22-470-D,BJJDY-14.0-22-470-D,BJJDY-14.5-22-470-D,BJJDY-15.0-22-470-D,BJJDY-15.5-22-470-D,BJJDY-16.0-22-470-D,BJJDY-16.5-22-470-D,BJJDY-17.5-22-470-D,BJJDY-7.0-22-470-S,BJJDY-7.2-22-470-S,BJJDY-7.5-22-470-S,BJJDY-8.5-22-470-S,BJJDY-9.0-22-470-S,BJJDY-9.5-22-470-S,BJJDY-10.0-22-470-S,BJJDY-10.5-22-470-S,BJJDY-11.0-22-470-S,BJJDY-11.5-22-470-S,BJJDY-12.0-22-470-S,BJJDY-12.5-22-470-S,BJJDY-13.0-22-470-S,BJJDY-13.5-22-470-S,BJJDY-14.0-22-470-S,BJJDY-14.5-22-470-S,BJJDY-15.0-22-470-S,BJJDY-15.5-22-470-S,BJJDY-16.0-22-470-S,BJJDY-16.5-22-470-S,BJJDY-17.5-22-470-S. BJJDRK-7.0-20-493-B,BJJDRK-7.5-20-493-B,BJJDRK-8.0-20-493-B,BJJDRK-8.5-20-493-B,BJJDRK-9.0-20-493-B,BJJDRK-9.5-20-493-B,BJJDRK-10.0-20-493-B,BJJDRK-10.5-20-493-B,BJJDRK-11.0-20-493-B,BJJDRK-11.5-20-493-B,BJJDRK-12.0-20-493-B,BJJDRK-12.5-20-493-B,BJJDRK-13.0-20-493-B,BJJDRK-13.5-20-493-B,BJJDRK-14.0-20-493-B,BJJDRK-14.5-20-493-B,BJJDRK-15.0-20-493-B,BJJDRK-15.5-20-493-B,BJJDRK-16.0-20-493-B,BJJDRK-16.5-20-493-B,BJJDRK-17.0-20-493-B,BJJDRK-17.5-20-493-B,BJJDRK-18.0-20-493-B,BJJDRK-7.0-20-493-D,BJJDRK-7.5-20-493-D,BJJDRK-8.0-20-493-D,BJJDRK-8.5-20-493-D,BJJDRK-9.0-20-493-D,BJJDRK-9.5-20-493-D,BJJDRK-10.0-20-493-D,BJJDRK-10.5-20-493-D,BJJDRK-11.0-20-493-D,BJJDRK-11.5-20-493-D,BJJDRK-12.0-20-493-D,BJJDRK-12.5-20-493-D,BJJDRK-13.0-20-493-D,BJJDRK-13.5-20-493-D,BJJDRK-14.0-20-493-D,BJJDRK-14.5-20-493-D,BJJDRK-15.0-20-493-D,BJJDRK-15.5-20-493-D,BJJDRK-16.0-20-493-D,BJJDRK-16.5-20-493-D,BJJDRK-17.0-20-493-D,BJJDRK-17.5-20-493-D,BJJDRK-18.0-20-493-D,BJJDRK-7.0-20-493-S,BJJDRK-7.5-20-493-S,BJJDRK-8.0-20-493-S,BJJDRK-8.5-20-493-S,BJJDRK-9.0-20-493-S,BJJDRK-9.5-20-493-S,BJJDRK-10.0-20-493-S,BJJDRK-10.5-20-493-S,BJJDRK-11.0-20-493-S,BJJDRK-11.5-20-493-S,BJJDRK-12.0-20-493-S,BJJDRK-12.5-20-493-S,BJJDRK-13.0-20-493-S,BJJDRK-13.5-20-493-S,BJJDRK-14.0-20-493-S,BJJDRK-14.5-20-493-S,BJJDRK-15.0-20-493-S,BJJDRK-15.5-20-493-S,BJJDRK-16.0-20-493-S,BJJDRK-16.5-20-493-S,BJJDRK-17.0-20-493-S,BJJDRK-17.5-20-493-S,BJJDRK-18.0-20-493-S. |
| 产品描述 | 由接头、杆部和有扩孔切削刃的刀头组成。采用不锈钢材料制成。非无菌提供。 |
| 预期用途 | 用于骨科手术中扩孔、铰孔、髓腔再造及扩大。 |
| 备案单位 | 上海市药品监督管理局 |
| 备案日期 | 2021-06-01 |
| 变更情况 | 一、根据2021年公布的《第一类医疗器械产品目录》实施通告第七项要求，变更如下内容： 1、产品描述由“由接头、杆部和具有扩孔切削刃的刀头组成。采用不锈钢材料制成。非无菌提供”变更为“由接头和具有扩孔切削刃的刀头组成。采用不锈钢材料制成。非无菌提供。使用前由使用机构根据说明书进行灭菌。不在内窥镜下使用。” 2、产品说明书及最小销售单元标签修订：①产品结构组成及材质“由接头、杆部和具有扩孔切削刃的刀头组成”变更为“由接头和具有扩孔切削刃的刀头组成。采用不锈钢材料制成。非无菌提供。使用前由使用机构根据说明书进行灭菌。不在内窥镜下使用。” 二、变更生产流程图。;2022-04-08 |
| 备案类型 | 暂无权限 |
扩展信息
