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一次性使用腔镜直线型切割吻合器及切割组件
苏械注准20222021927
常州市新北区天山路20号
2023-08-22
2027-10-31
一次性使用腔镜直线型切割吻合器及切割组件由器身和组件组成,器身由联杆外壳、旋转轴套 、转向旋钮、把手、保险按钮、手柄外壳、复位帽组成;组件由钉匣外壳、钉匣底座、钉砧、引导头、钉仓、切割刀、吻合钉组成。器身与组件分开独立包装。该产品以无菌状态提供,经环氧乙烷灭菌。一次性使用。
适用于开放或腔镜下的外科手术中,肺、支气管组织及胃、肠切除、横断和吻合。
2023-08-22型号、规格变更 由“器身:RLSJ-S、RLSJ-C、RLSJ-E组件:RTF45A、RTF45W、RTF45B、RTF60B、RTF45J、RTF60J、RTC30H、RTC45H、RTC60H、RTC45P、RTC60P、RTL45A、RTL45W、RTL45B、RTL60B、RTL45J、RTL60J、RTL45G、RTL60G”变更为“器身:RLSJ-S、RLSJ-C、RLSJ-E、RLST-S、RLST-C、RLST-E组件:RTF45A、RTF45W、RTF45B、RTF60B、RTF45J、RTF60J、RTC30H、RTC45H、RTC60H、RTC45P、RTC60P、RTL45A、RTL45W、RTL45B、RTL60B、RTL45J、RTL60J、RTL45G、RTL60G、RTS30H、RTS45H、RTS60H、RTS30P、RTS45P、RTS60P、RTS30D、RTS45D、RTS60D”
无锡市锡山区经济技术开发区尤沈路 26 号(委托生产);无锡市锡山经济 技术开发区芙蓉中三路 99 号瑞云 4 座 201- 216(委托生产)
器身:RLSJ-S、RLSJ-C、RLSJ-E、RLST-S、RLST-C、RLST-E组件:RTF45A、RTF45W、RTF45B、RTF60B、RTF45J、RTF60J、RTC30H、RTC45H、RTC60H、RTC45P、RTC60P、RTL45A、RTL45W、RTL45B、RTL60B、RTL45J、RTL60J、RTL45G、RTL60G、RTS30H、RTS45H、RTS60H、RTS30P、RTS45P、RTS60P、RTS30D、RTS45D、RTS60D
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第二类
本文件与“苏械注准20222021927”医疗器械注册证共同使用