| 产品名称 | 多功能手术解剖器（电凝切割器） |
|---|---|
| 结构及组成/主要组成成分 | 单极型产品由电极、功能管、绝缘管、塑料柄部(可带LED光源灯)、手控按钮开关、吸引管及接头、电缆线、插头、铁氟龙材料(不粘涂层)组成。电极头部采用医用不锈钢或金属钨或医用不锈钢带不粘涂层材料制成。双极型产品采用医用不锈钢或铜、绝缘层、滴水管、柄部、电缆线组成。 |
| 适用范围/预期用途 | 产品供手术时与高频电凝设备和/或吸引器配套进行电凝、钝切、照明、刮爬及吸除用，不用于内窥镜外科手术。 |
| 型号规格 | 单级：WP-P10S、WP-P20S、WP-P20TS、WP-P21S、WP-P30S、WP-P35S、WP-P36S、WP-Y70S、WP-Y71S、WP-Y72S、WP-Y73S、WP-Y90S、WP-Y91S、WP-Y92S、WP-Y93S、WP-D100S、WP-D103S、WP-F18S、WP-Y070K、WP-Y071K、WP-Y072K、WP-Y073K、WP-T330K、WP-Y330K、WP-T350K、WP-Y350K、WP-D010K、WP-D011K、WP-Y090K、WP-Y091K、WP-Y092K、WP-Y093K、WP-B100S、WP-B100TS、WP-B101S、WP-B200S、WP-B200TS、WP-B202S、WP-B203TS、WP-B301S、WP-C100S、WP-C101S、WP-C200S、WP-C201S、WP-C202S、WP-C301S、WP-L30S、WP-L31S、WP-L32S、WP-L33S、WP-L34S、WP-L35S、WP-L36S、WP-L37S、WP-L38S、WP-L39S、WP-L40S、WP-L41S、WP-L42S、WP-L43S、WP-L44S、WP-L45S、WP-L46S、WP-L47S、WP-L48S、WP-S62S、WP-S64S、WP-B76S、WP-B77S、WP-B78S、WP-B79S、WP-B80S、WP-B81S、WP-B82S、WP-B83S、WP-B84S、WP-E95S、WP-E94S、WP-E102S、WP-E103S、WP-E104S、WP-N100S、WP-E101S、WP-N101S、WP-N200S、WP-N201S、WP-E301S、WP-N300S、WP-N301S、WP-B85S、WP-B86S、WP-B87S、WP-B90S、WP-B95S、WP-B75S、WP-E401S、WP-E402S、WP-E403S、WP-E404S、WP-E405S、WP-E406S、WP-E407S、WP-E408S、WP-E423S、WP-E425S、WP-E45、WP-E45、WP-E75、WP-ET55、WP-ET125、WP-ET180、WP-EX150、WP-EX105、WP-EX75、WP-EY150、WP-EY100、WP-EL150、WP-EL120、WP-E70、WP-E60、WP-EX55、WP-E55S、WP-E86S、WP-E62S；双极：WK-01S05110F、WK-01S05130F、WK-01S05160F、WK-02S05130F、WK-01B05185F、WK-01B05200F、WK-01B10220F、WK-02B10165DF、WK-02B10200DF、WK-02B10230DF、WK-03B10165DF、WK-03B10200DF、WK-03B10230DF、WK-04B10230DF、WK-05B10210F、WK-06B05210F、WK-07B05200F、WK-07B05210F、WK-07B05240F、WK-07B05330F |
| 注册证编号 | 湘械注准20212011720 |
| 注册人名称 | 荣佳（湖南）医疗器械制造有限公司 |
| 注册人住所 | 湖南省衡阳市衡南县新县城工业园内 |
| 生产地址 | 湖南省衡阳市衡南县新县城工业园内 |
| 批准日期 | 2021-09-16 |
| 有效期至 | 2026-09-15 |
| 编码代号2018 | 暂无权限 |
| 管理分类 | 暂无权限 |
| 企业联系电话 | 暂无权限 |
| 指导原则 | 暂无权限 |
| 相关标准 | 暂无权限 |
| 临床路径 | 暂无权限 |
| 共性问题 | 暂无权限 |
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