国食药监械(进)字2008第3220738号

RUDOLF MEDICAL GmbH +Co.KG

Zollerstrasse 1，D-78567 Fridingen，Germany

Zollerstrasse 1，D-78567 Fridingen，Germany

北京诺道夫医疗器械技术有限公司

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关节镜及附件 Arthroscopy

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见附录

该产品由关节镜与其附件(见附录)构成。外径：1.7mm(RU0156-20/15)/2mm(RU0156-17/15、RU0156-20/00)/2.7mm(RU0140-12、RU0141-12、RU0142-12、RU0143-12、RU0143-18、RU0144-12、RU0144-18、RU0145-12、RU0145-18、RU0151-45)/4mm(RU0150-14、RU0151-14、RU0152-14、RU0155-20/00、RU0155-20/15、RU0156-17/00)，允差±5%。工作长度：58mm(RU0155-20/00、RU0155-20/15)/104mm(RU0156-17/00、RU0156-17/15、RU0156-20/00、RU0156-20/15)/110mm(RU0140-12、RU0141-12、RU0142-12)/175mm(RU0143-12、RU0144-12、RU0145-12、RU0150-14、RU0151-14、RU0151-45、RU0152-14)/187.5mm(RU0143-18、RU0144-18、RU0145-18),允差±3%。视场角：70°(RU0140-12、RU0141-12、RU0143-12、RU0144-12、RU0144-18、RU0155-20/15、RU0156-17/15、RU0156-20/15)/75°(RU0142-12、RU0143-18、RU0145-12、RU0151-45)/80°(RU0150-14、RU0152-14、RU0155-20/00、RU0156-17/00、RU0156-20/00)/98°(RU0151-14)/100°(RU0145-18),极限偏差-5%到15%。视向角，0°(RU0140-12、RU0143-12、RU0143-18、RU0150-14、RU0155-20/00、RU0156-17/00、RU0156-20/00)/15°(RU0155-20/15、RU0156-17/15、RU0156-20/15)/30°(RU0141-12、RU0144-12、RU0144-18、RU0151-14)/45°(RU0151-45)/70°(RU0142-12、RU0142-12、RU0145-18、RU0152-14),允差±10%。放大率≥1(L=20mm)。分辨率≥3.6Lp/mm(L=20mm)。

该产品临床适用于人体各大小关节的检查和手术。

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2008.04.01

2012.03.31

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