产品名称 | 一次性使用穿刺活检针 |
---|---|
结构及组成/主要组成成分 | 一次性使用穿刺活检针由外针座、外针管、内针杆、内针座和保护套组成。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 | 用于从肝脏、脾脏、肾脏、肺、淋巴、乳房、前列腺及甲状腺获取组织进行活检。 |
型号规格 | BN-MAR-1/1.6(16G)×40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/1.4(17G)×40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/1.2(18G)×40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/1.1(19G)×40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/0.9(20G)×40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/0.8(21G)×40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/0.7(22G)×40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/0.6(23G)×40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/0.55(24G)×40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/0.5(25G)×40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/0.45(26G)×40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/0.4(27G)×40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350) |
产品储存条件及有效期 | 不适用 |
注册证编号 | 苏械注准20232141398 |
注册人名称 | 安隽医疗科技(南京)有限公司 |
注册人住所 | 南京市江北新区万寿路15号J3幢202室 |
生产地址 | 南京市江北新区万寿路15号J3幢2楼 |
备注 | 本文件与“苏械注准20232141398”医疗器械注册证共同使用 |
批准日期 | 2024-08-30 |
有效期至 | 2028-10-06 |
变更情况 | 2024-08-30适用范围变更 由“用于从肝脏、脾脏、肾脏、肺、淋巴、乳房及前列腺获取组织进行活检。”变更为“用于从肝脏、脾脏、肾脏、肺、淋巴、乳房、前列腺及甲状腺获取组织进行活检。”产品技术要求变更 由“技术要求变更情况对比表原条款及内容”变更为“技术要求变更情况对比表修改后条款及内容”型号、规格变更 由“BN-MAR-1/1.6(16G)X40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/1.4(17G)X40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/1.2(18G)X40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/1.1(19G)X40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/0.9(20G)X40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/0.8(21G)X40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/0.7(22G)X40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/0.6(23G)X40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/0.55(24G)X40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/0.5(25G)X40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/0.45(26G)X40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/0.4(27G)X40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)”变更为“BN-MAR-1/1.6(16G)×40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/1.4(17G)×40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/1.2(18G)×40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/1.1(19G)×40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/0.9(20G)×40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/0.8(21G)×40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/0.7(22G)×40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/0.6(23G)×40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/0.55(24G)×40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/0.5(25G)×40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/0.45(26G)×40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)BN-MAR-1/0.4(27G)×40(50,60,70,80,90,100,110,120,130,140,150,160,170,180,190,200,210,220,230,240,250,260,270,280,290,300,310,320,330,340,350)” |
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