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脊柱用手術(shù)工具包 Medtronic Reusable Instruments
國(guó)械備20151206
1800 Pyramid Place,Memphis,TN 38132,USA
2015-08-11
脊柱用手術(shù)工具包由脊柱用手術(shù)工具包由試模、微創(chuàng)牽開(kāi)器、快裝手柄、骨錘、扳手、起子、骨導(dǎo)引針、神經(jīng)根拉鉤、骨科吸引器、骨科撐開(kāi)器組成,其中試模、微創(chuàng)牽開(kāi)器、骨錘、扳手、起子、骨導(dǎo)引針、神經(jīng)根拉鉤、骨科吸引器、骨科撐開(kāi)器產(chǎn)品均在國(guó)家食品藥品監(jiān)督管理總局發(fā)布的一類(lèi)產(chǎn)品目錄中,快裝手柄在食藥監(jiān)辦械管[2015]69號(hào)文中。詳細(xì)產(chǎn)品描述見(jiàn)申請(qǐng)表附頁(yè)。
用于脊柱外科手術(shù)。各組成部件的預(yù)期用途見(jiàn)申請(qǐng)表附頁(yè)。
美敦力(上海)管理有限公司
中國(guó)(上海)自由貿(mào)易試驗(yàn)區(qū)日京路180號(hào)第三層
1. Werftstr.17, 94469 Deggendorf, GERMANY; 2. Road 909 Km. 0.4 Bo, 00792 Barrio Marina, Humacao, PUERTO RICO USA; 3. 4340 Swinnea Road, Memphis TN 38118, USA; 4. 2500 Silveus Crossing, Warsaw, IN 46582, USA.
見(jiàn)附頁(yè)(附件鏈接地址:http://www.cmdi.org.cn/upload/pdf/ylbapdf/gxb20151206.pdf)
第一類(lèi)
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