| 注册证编号 | 京械注准20172020796 [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 | WAF21YL30WAF21YL40WAF21YL45WAF21YL55WAF21YL60WAF25YL30WAF25YL40WAF25YL45WAF25YL55WAF25YL60WAF29YL30WAF29YL40WAF29YL45WAF29YL55WAF29YL60WAF32YL30WAF32YL40WAF32YL45WAF32YL55WAF32YL60WAF33YL30WAF33YL40WAF33YL45WAF33YL55WAF33YL60WAF34YL30WAF34YL40WAF34YL45WAF34YL55WAF34YL60WAF21YM30WAF21YM40WAF21YM45WAF21YM55WAF21YM60WAF25YM30WAF25YM40WAF25YM45WAF25YM55WAF25YM60WAF29YM30WAF29YM40WAF29YM45WAF29YM55WAF29YM60WAF32YM30WAF32YM40WAF32YM45WAF32YM55WAF32YM60WAF33YM30WAF33YM40WAF33YM45WAF33YM55WAF33YM60WAF34YM30WAF34YM40WAF34YM45WAF34YM55WAF34YM60WBF21YL30WBF21YL40WBF21YL45WBF21YL55WBF21YL60WBF25YL30WBF25YL40WBF25YL45WBF25YL55WBF25YL60WBF29YL30WBF29YL40WBF29YL45WBF29YL55WBF29YL60WBF32YL30WBF32YL40WBF32YL45WBF32YL55WBF32YL60WBF33YL30WBF33YL40WBF33YL45WBF33YL55WBF33YL60WBF34YL30WBF34YL40WBF34YL45WBF34YL55WBF34YL60WBF21YM30WBF21YM40WBF21YM45WBF21YM55WBF21YM60WBF25YM30WBF25YM40WBF25YM45WBF25YM55WBF25YM60WBF29YM30WBF29YM40WBF29YM45WBF29YM55WBF29YM60WBF32YM30WBF32YM40WBF32YM45WBF32YM55WBF32YM60WBF33YM30WBF33YM40WBF33YM45WBF33YM55WBF33YM60WBF34YM30WBF34YM40WBF34YM45WBF34YM55WBF34YM60WCF21YL30WCF21YL40WCF21YL45WCF21YL55WCF21YL60WCF24YL30WCF24YL40WCF24YL45WCF24YL55WCF24YL60WCF25YL30WCF25YL40WCF25YL45WCF25YL55WCF25YL60WCF26YL30WCF26YL40WCF26YL45WCF26YL55WCF26YL60WCF28YL30WCF28YL40WCF28YL45WCF28YL55WCF28YL60WCF29YL30WCF29YL40WCF29YL45WCF29YL55WCF29YL60WCF32YL30WCF32YL40WCF32YL45WCF32YL55WCF32YL60WCF34YL30WCF34YL40WCF34YL45WCF34YL55WCF34YL60WCF21YM30WCF21YM40WCF21YM45WCF21YM55WCF21YM60WCF24YM30WCF24YM40WCF24YM45WCF24YM55WCF24YM60WCF25YM30WCF25YM40WCF25YM45WCF25YM55WCF25YM60WCF26YM30WCF26YM40WCF26YM45WCF26YM55WCF26YM60WCF28YM30WCF28YM40WCF28YM45WCF28YM55WCF28YM60WCF29YM30WCF29YM40WCF29YM45WCF29YM55WCF29YM60WCF32YM30WCF32YM40WCF32YM45WCF32YM55WCF32YM60WCF34YM30WCF34YM40WCF34YM45WCF34YM55WCF34YM60WDF21YL30WDF21YL40WDF21YL45WDF21YL55WDF21YL60WDF24YL30WDF24YL40WDF24YL45WDF24YL55WDF24YL60WDF26YL30WDF26YL40WDF26YL45WDF26YL55WDF26YL60WDF28YL30WDF28YL40WDF28YL45WDF28YL55WDF28YL60WDF29YL30WDF29YL40WDF29YL45WDF29YL55WDF29YL60WDF32YL30WDF32YL40WDF32YL45WDF32YL55WDF32YL60WDF34YL30WDF34YL40WDF34YL45WDF34YL55WDF34YL60WDF21YM30WDF21YM40WDF21YM45WDF21YM55WDF21YM60WDF24YM30WDF24YM40WDF24YM45WDF24YM55WDF24YM60WDF26YM30WDF26YM40WDF26YM45WDF26YM55WDF26YM60WDF28YM30WDF28YM40WDF28YM45WDF28YM55WDF28YM60WDF29YM30WDF29YM40WDF29YM45WDF29YM55WDF29YM60WDF32YM30WDF32YM40WDF32YM45WDF32YM55WDF32YM60WDF34YM30WDF34YM40WDF34YM45WDF34YM55WDF34YM60WEF21YL30WEF21YL40WEF21YL45WEF21YL55WEF21YL60WEF24YL30WEF24YL40WEF24YL45WEF24YL55WEF24YL60WEF26YL30WEF26YL40WEF26YL45WEF26YL55WEF26YL60WEF28YL30WEF28YL40WEF28YL45WEF28YL55WEF28YL60WEF29YL30WEF29YL40WEF29YL45WEF29YL55WEF29YL60WEF32YL30WEF32YL40WEF32YL45WEF32YL55WEF32YL60WEF34YL30WEF34YL40WEF34YL45WEF34YL55WEF34YL60WEF21YM30WEF21YM40WEF21YM45WEF21YM55WEF21YM60WEF24YM30WEF24YM40WEF24YM45WEF24YM55WEF24YM60WEF26YM30WEF26YM40WEF26YM45WEF26YM55WEF26YM60WEF28YM30WEF28YM40WEF28YM45WEF28YM55WEF28YM60WEF29YM30WEF29YM40WEF29YM45WEF29YM55WEF29YM60WEF32YM30WEF32YM40WEF32YM45WEF32YM55WEF32YM60WEF34YM30WEF34YM40WEF34YM45WEF34YM55WEF34YM60WFF21YL30WFF21YL40WFF21YL45WFF21YL55WFF21YL60WFF24YL30WFF24YL40WFF24YL45WFF24YL55WFF24YL60WFF26YL30WFF26YL40WFF26YL45WFF26YL55WFF26YL60WFF28YL30WFF28YL40WFF28YL45WFF28YL55WFF28YL60WFF29YL30WFF29YL40WFF29YL45WFF29YL55WFF29YL60WFF32YL30WFF32YL40WFF32YL45WFF32YL55WFF32YL60WFF34YL30WFF34YL40WFF34YL45WFF34YL55WFF34YL60WFF21YM30WFF21YM40WFF21YM45WFF21YM55WFF21YM60WFF24YM30WFF24YM40WFF24YM45WFF24YM55WFF24YM60WFF26YM30WFF26YM40WFF26YM45WFF26YM55WFF26YM60WFF28YM30WFF28YM40WFF28YM45WFF28YM55WFF28YM60WFF29YM30WFF29YM40WFF29YM45WFF29YM55WFF29YM60WFF32YM30WFF32YM40WFF32YM45WFF32YM55WFF32YM60WFF34YM30WFF34YM40WFF34YM45WFF34YM55WFF34YM60 |
| 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）产品及一次性使用线形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 |
