| 注册证编号 | 京械注准20172020788 [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 | WAE21YL30WAE21YL40WAE21YL45WAE21YL55WAE21YL60WAE24YL30WAE24YL40WAE24YL45WAE24YL55WAE24YL60WAE26YL30WAE26YL40WAE26YL45WAE26YL55WAE26YL60WAE28YL30WAE28YL40WAE28YL45WAE28YL55WAE28YL60WAE29YL30WAE29YL40WAE29YL45WAE29YL55WAE29YL60WAE32YL30WAE32YL40WAE32YL45WAE32YL55WAE32YL60WAE34YL30WAE34YL40WAE34YL45WAE34YL55WAE34YL60WAE21YM30WAE21YM40WAE21YM45WAE21YM55WAE21YM60WAE24YM30WAE24YM40WAE24YM45WAE24YM55WAE24YM60WAE26YM30WAE26YM40WAE26YM45WAE26YM55WAE26YM60WAE28YM30WAE28YM40WAE28YM45WAE28YM55WAE28YM60WAE29YM30WAE29YM40WAE29YM45WAE29YM55WAE29YM60WAE32YM30WAE32YM40WAE32YM45WAE32YM55WAE32YM60WAE34YM30WAE34YM40WAE34YM45WAE34YM55WAE34YM60WBE21YL30WBE21YL40WBE21YL45WBE21YL55WBE21YL60WBE24YL30WBE24YL40WBE24YL45WBE24YL55WBE24YL60WBE26YL30WBE26YL40WBE26YL45WBE26YL55WBE26YL60WBE28YL30WBE28YL40WBE28YL45WBE28YL55WBE28YL60WBE29YL30WBE29YL40WBE29YL45WBE29YL55WBE29YL60WBE32YL30WBE32YL40WBE32YL45WBE32YL55WBE32YL60WBE34YL30WBE34YL40WBE34YL45WBE34YL55WBE34YL60WBE21YM30WBE21YM40WBE21YM45WBE21YM55WBE21YM60WBE24YM30WBE24YM40WBE24YM45WBE24YM55WBE24YM60WBE26YM30WBE26YM40WBE26YM45WBE26YM55WBE26YM60WBE28YM30WBE28YM40WBE28YM45WBE28YM55WBE28YM60WBE29YM30WBE29YM40WBE29YM45WBE29YM55WBE29YM60WBE32YM30WBE32YM40WBE32YM45WBE32YM55WBE32YM60WBE34YM30WBE34YM40WBE34YM45WBE34YM55WBE34YM60WCE21YL30WCE21YL40WCE21YL45WCE21YL55WCE21YL60WCE24YL30WCE24YL40WCE24YL45WCE24YL55WCE24YL60WCE25YL30WCE25YL40WCE25YL45WCE25YL55WCE25YL60WCE26YL30WCE26YL40WCE26YL45WCE26YL55WCE26YL60WCE28YL30WCE28YL40WCE28YL45WCE28YL55WCE28YL60WCE29YL30WCE29YL40WCE29YL45WCE29YL55WCE29YL60WCE32YL30WCE32YL40WCE32YL45WCE32YL55WCE32YL60WCE34YL30WCE34YL40WCE34YL45WCE34YL55WCE34YL60WCE21YM30WCE21YM40WCE21YM45WCE21YM55WCE21YM60WCE24YM30WCE24YM40WCE24YM45WCE24YM55WCE24YM60WCE25YM30WCE25YM40WCE25YM45WCE25YM55WCE25YM60WCE26YM30WCE26YM40WCE26YM45WCE26YM55WCE26YM60WCE28YM30WCE28YM40WCE28YM45WCE28YM55WCE28YM60WCE29YM30WCE29YM40WCE29YM45WCE29YM55WCE29YM60WCE32YM30WCE32YM40WCE32YM45WCE32YM55WCE32YM60WCE34YM30WCE34YM40WCE34YM45WCE34YM55WCE34YM60 |
| 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 |
