| 注册证编号 | 京械注准20172020797 [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 | WAF21VI30WAF21VI45WAF21VI60WAF25VI30WAF25VI45WAF25VI60WAF29VI30WAF29VI45WAF29VI60WAF32VI30WAF32VI45WAF32VI60WAF33VI30WAF33VI45WAF33VI60WAF34VI30WAF34VI45WAF34VI60WAF21VJ30WAF21VJ45WAF21VJ60WAF25VJ30WAF25VJ45WAF25VJ60WAF29VJ30WAF29VJ45WAF29VJ60WAF32VJ30WAF32VJ45WAF32VJ60WAF33VJ30WAF33VJ45WAF33VJ60WAF34VJ30WAF34VJ45WAF34VJ60WAF21VK30WAF21VK45WAF21VK60WAF25VK30WAF25VK45WAF25VK60WAF29VK30WAF29VK45WAF29VK60WAF32VK30WAF32VK45WAF32VK60WAF33VK30WAF33VK45WAF33VK60WAF34VK30WAF34VK45WAF34VK60WBF21VI30WBF21VI45WBF21VI60WBF25VI30WBF25VI45WBF25VI60WBF29VI30WBF29VI45WBF29VI60WBF32VI30WBF32VI45WBF32VI60WBF33VI30WBF33VI45WBF33VI60WBF34VI30WBF34VI45WBF34VI60WBF21VJ30WBF21VJ45WBF21VJ60WBF25VJ30WBF25VJ45WBF25VJ60WBF29VJ30WBF29VJ45WBF29VJ60WBF32VJ30WBF32VJ45WBF32VJ60WBF33VJ30WBF33VJ45WBF33VJ60WBF34VJ30WBF34VJ45WBF34VJ60WBF21VK30WBF21VK45WBF21VK60WBF25VK30WBF25VK45WBF25VK60WBF29VK30WBF29VK45WBF29VK60WBF32VK30WBF32VK45WBF32VK60WBF33VK30WBF33VK45WBF33VK60WBF34VK30WBF34VK45WBF34VK60WCF21VI30WCF21VI45WCF21VI60WCF24VI30WCF24VI45WCF24VI60WCF25VI30WCF25VI45WCF25VI60WCF26VI30WCF26VI45WCF26VI60WCF28VI30WCF28VI45WCF28VI60WCF29VI30WCF29VI45WCF29VI60WCF32VI30WCF32VI45WCF32VI60WCF34VI30WCF34VI45WCF34VI60WCF21VJ30WCF21VJ45WCF21VJ60WCF24VJ30WCF24VJ45WCF24VJ60WCF25VJ30WCF25VJ45WCF25VJ60WCF26VJ30WCF26VJ45WCF26VJ60WCF28VJ30WCF28VJ45WCF28VJ60WCF29VJ30WCF29VJ45WCF29VJ60WCF32VJ30WCF32VJ45WCF32VJ60WCF34VJ30WCF34VJ45WCF34VJ60WCF21VK30WCF21VK45WCF21VK60WCF24VK30WCF24VK45WCF24VK60WCF25VK30WCF25VK45WCF25VK60WCF26VK30WCF26VK45WCF26VK60WCF28VK30WCF28VK45WCF28VK60WCF29VK30WCF29VK45WCF29VK60WCF32VK30WCF32VK45WCF32VK60WCF34VK30WCF34VK45WCF34VK60WDF21VI30WDF21VI45WDF21VI60WDF24VI30WDF24VI45WDF24VI60WDF26VI30WDF26VI45WDF26VI60WDF28VI30WDF28VI45WDF28VI60WDF29VI30WDF29VI45WDF29VI60WDF32VI30WDF32VI45WDF32VI60WDF34VI30WDF34VI45WDF34VI60WDF21VJ30WDF21VJ45WDF21VJ60WDF24VJ30WDF24VJ45WDF24VJ60WDF26VJ30WDF26VJ45WDF26VJ60WDF28VJ30WDF28VJ45WDF28VJ60WDF29VJ30WDF29VJ45WDF29VJ60WDF32VJ30WDF32VJ45WDF32VJ60WDF34VJ30WDF34VJ45WDF34VJ60WDF21VK30WDF21VK45WDF21VK60WDF24VK30WDF24VK45WDF24VK60WDF26VK30WDF26VK45WDF26VK60WDF28VK30WDF28VK45WDF28VK60WDF29VK30WDF29VK45WDF29VK60WDF32VK30WDF32VK45WDF32VK60WDF34VK30WDF34VK45WDF34VK60WEF21VI30WEF21VI45WEF21VI60WEF24VI30WEF24VI45WEF24VI60WEF26VI30WEF26VI45WEF26VI60WEF28VI30WEF28VI45WEF28VI60WEF29VI30WEF29VI45WEF29VI60WEF32VI30WEF32VI45WEF32VI60WEF34VI30WEF34VI45WEF34VI60WEF21VJ30WEF21VJ45WEF21VJ60WEF24VJ30WEF24VJ45WEF24VJ60WEF26VJ30WEF26VJ45WEF26VJ60WEF28VJ30WEF28VJ45WEF28VJ60WEF29VJ30WEF29VJ45WEF29VJ60WEF32VJ30WEF32VJ45WEF32VJ60WEF34VJ30WEF34VJ45WEF34VJ60WEF21VK30WEF21VK45WEF21VK60WEF24VK30WEF24VK45WEF24VK60WEF26VK30WEF26VK45WEF26VK60WEF28VK30WEF28VK45WEF28VK60WEF29VK30WEF29VK45WEF29VK60WEF32VK30WEF32VK45WEF32VK60WEF34VK30WEF34VK45WEF34VK60WFF21VI30WFF21VI45WFF21VI60WFF24VI30WFF24VI45WFF24VI60WFF26VI30WFF26VI45WFF26VI60WFF28VI30WFF28VI45WFF28VI60WFF29VI30WFF29VI45WFF29VI60WFF32VI30WFF32VI45WFF32VI60WFF34VI30WFF34VI45WFF34VI60WFF21VJ30WFF21VJ45WFF21VJ60WFF24VJ30WFF24VJ45WFF24VJ60WFF26VJ30WFF26VJ45WFF26VJ60WFF28VJ30WFF28VJ45WFF28VJ60WFF29VJ30WFF29VJ45WFF29VJ60WFF32VJ30WFF32VJ45WFF32VJ60WFF34VJ30WFF34VJ45WFF34VJ60WFF21VK30WFF21VK45WFF21VK60WFF24VK30WFF24VK45WFF24VK60WFF26VK30WFF26VK45WFF26VK60WFF28VK30WFF28VK45WFF28VK60WFF29VK30WFF29VK45WFF29VK60WFF32VK30WFF32VK45WFF32VK60WFF34VK30WFF34VK45WFF34VK60 |
| 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一次性使用管型吻合器（FCSLF系列）、一次性使用管型吻合器（FCSMF系列）、一次性使用管型吻合器（FCSSWF系列）、一次性使用管型吻合器（FCSSMF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 |
