| 注册证编号 | 京械注准20172020794 [查看相关产品信息] |
| 注册人名称 | 北京派尔特医疗科技股份有限公司[查看公司信息] |
| 注册人住所 | 北京市昌平区北七家镇上承路8号 |
| 生产地址 | 北京市昌平区北七家镇上承路 8 号 A区、B区、C区,北京市昌平区科技园区火炬街28号,北京市朝阳区金盏大街西路白桥工业区西侧2号,北京市昌平区北七家镇亚市南路 C8 号 |
| 产品名称 | 一次性使用吻合器组合包 |
| 管理类别 | 第二类 |
| 型号规格 | WAE21VI30WAE21VI45WAE21VI60WAE24VI30WAE24VI45WAE24VI60WAE26VI30WAE26VI45WAE26VI60WAE28VI30WAE28VI45WAE28VI60WAE29VI30WAE29VI45WAE29VI60WAE32VI30WAE32VI45WAE32VI60WAE34VI30WAE34VI45WAE34VI60WAE21VJ30WAE21VJ45WAE21VJ60WAE24VJ30WAE24VJ45WAE24VJ60WAE26VJ30WAE26VJ45WAE26VJ60WAE28VJ30WAE28VJ45WAE28VJ60WAE29VJ30WAE29VJ45WAE29VJ60WAE32VJ30WAE32VJ45WAE32VJ60WAE34VJ30WAE34VJ45WAE34VJ60WAE21VK30WAE21VK45WAE21VK60WAE24VK30WAE24VK45WAE24VK60WAE26VK30WAE26VK45WAE26VK60WAE28VK30WAE28VK45WAE28VK60WAE29VK30WAE29VK45WAE29VK60WAE32VK30WAE32VK45WAE32VK60WAE34VK30WAE34VK45WAE34VK60WBE21VI30WBE21VI45WBE21VI60WBE24VI30WBE24VI45WBE24VI60WBE26VI30WBE26VI45WBE26VI60WBE28VI30WBE28VI45WBE28VI60WBE29VI30WBE29VI45WBE29VI60WBE32VI30WBE32VI45WBE32VI60WBE34VI30WBE34VI45WBE34VI60WCE21VI30WCE21VI45WCE21VI60WCE24VI30WCE24VI45WCE24VI60WCE25VI30WCE25VI45WCE25VI60WCE26VI30WCE26VI45WCE26VI60WCE28VI30WCE28VI45WCE28VI60WCE29VI30WCE29VI45WCE29VI60WCE32VI30WCE32VI45WCE32VI60WCE34VI30WCE34VI45WCE34VI60WCE21VJ30WCE21VJ45WCE21VJ60WCE24VJ30WCE24VJ45WCE24VJ60WCE25VJ30WCE25VJ45WCE25VJ60WCE26VJ30WCE26VJ45WCE26VJ60WCE28VJ30WCE28VJ45WCE28VJ60WCE29VJ30WCE29VJ45WCE29VJ60WCE32VJ30WCE32VJ45WCE32VJ60WCE34VJ30WCE34VJ45WCE34VJ60WCE21VK30WCE21VK45WCE21VK60WCE24VK30WCE24VK45WCE24VK60WCE25VK30WCE25VK45WCE25VK60WCE26VK30WCE26VK45WCE26VK60WCE28VK30WCE28VK45WCE28VK60WCE29VK30WCE29VK45WCE29VK60WCE32VK30WCE32VK45WCE32VK60WCE34VK30WCE34VK45WCE34VK60 |
| 结构及组成/主要组成成分 | 一次性使用吻合器组合包产品是将已取得注册证书的管型吻合器（FCSLE系列）、一次性使用管型吻合器及组件（FCSME系列）产品及一次性使用腔镜下切割吻合器系列产品组合而成。 |
| 适用范围/预期用途 | 适用于胃、肺等组织和消化道手术吻合用。 |
| 审批部门 | 北京市药品监督管理局 |
| 批准日期 | 2022/1/20 |
| 生效日期 | 2022/1/20 |
| 有效期至 | 2027/7/23 |
