| 器械名称 | 橡皮障 |
|---|---|
| 备案号 | 粤深械备20240117号 |
| 备案人名称 | 深圳市乐捷医疗器械有限公司 |
| 企业联系电话 | 暂无权限 |
| 备案人注册地址 | 广东省深圳市龙岗区坂田街道岗头社区天安云谷产业园二期(0207地块)6栋3109 |
| 生产地址 | 广东省惠州市惠城区水口街道岃洛六路6号第五栋101、201、801房（委托惠州市德嘉医疗科技有限公司生产） |
| 型号规格 | Blue(0.14mm,5"X5"), Green(0.14mm,5"X5"), Black(0.14mm,5"X5"), Pink(0.14mm,5"X5"), Yellow(0.14mm,5"X5"), Red(0.14mm,5"X5"), Orange(0.14mm,5"X5"), Blue(0.18mm,5"X5"), Green(0.18mm,5"X5"), Black(0.18mm,5"X5"), Pink(0.18mm,5"X5"), Yellow(0.18mm,5"X5"), Red(0.18mm,5"X5"), Orange(0.18mm,5"X5"), Blue(0.22mm,5"X5"), Green(0.22mm,5"X5"), Black(0.22mm,5"X5"), Pink(0.22mm,5"X5"), Yellow(0.22mm,5"X5"), Red(0.22mm,5"X5"), Orange(0.22mm,5"X5"), Blue(0.26mm,5"X5"), Green(0.26mm,5"X5"), Black(0.26mm,5"X5"), Pink(0.26mm,5"X5"), Yellow(0.26mm,5"X5"), Red(0.26mm,5"X5"),Orange(0.26mm,5"X5"), Blue(0.14mm,6"X6"), Green(0.14mm,6"X6"), Black(0.14mm,6"X6"), Pink(0.14mm,6"X6"), Yellow(0.14mm,6"X6"), Red(0.14mm,6"X6"), Orange(0.14mm,6"X6"), Blue(0.18mm,6"X6"), Green(0.18mm,6"X6"), Black(0.18mm,6"X6"), Pink(0.18mm,6"X6"), Yellow(0.18mm,6"X6"), Red(0.18mm,6"X6"), Orange(0.18mm,6"X6"), Blue(0.22mm,6"X6"), Green(0.22mm,6"X6"), Black(0.22mm,6"X6"), Pink(0.22mm,6"X6"), Yellow(0.22mm,6"X6"), Red(0.22mm,6"X6"), Orange(0.22mm,6"X6"), Blue(0.26mm,6"X6"), Green(0.26mm,6"X6"), Black(0.26mm,6"X6"), Pink(0.26mm,6"X6"), Yellow(0.26mm,6"X6"), Red(0.26mm,6"X6"), Orange(0.26mm,6"X6"), Blue(0.14mm,5"X5.5M), Green(0.14mm,5"X5.5M), Black(0.14mm,5"X5.5M), Pink(0.14mm,5"X5.5M), Yellow(0.14mm,5"X5.5M), Red(0.14mm,5"X5.5M), Orange(0.14mm,5"X5.5M), Blue(0.18mm,5"X5.5M), Green(0.18mm,5"X5.5M), Black(0.18mm,5"X5.5M), Pink(0.18mm,5"X5.5M), Yellow(0.18mm,5"X5.5M), Red(0.18mm,5"X5.5M), Orange(0.18mm,5"X5.5M), Blue(0.22mm,5"X5.5M), Green(0.22mm,5"X5.5M), Black(0.22mm,5"X5.5M), Pink(0.22mm,5"X5.5M), Yellow(0.22mm,5"X5.5M), Red(0.22mm,5"X5.5M), Orange(0.22mm,5"X5.5M), Blue(0.26mm,5"X5.5M), Green(0.26mm,5"X5.5M), Black(0.26mm,5"X5.5M), Pink(0.26mm,5"X5.5M), Yellow(0.26mm,5"X5.5M), Red(0.26mm,5"X5.5M), Orange(0.26mm,5"X5.5M), Blue(0.14mm,6"X5.5M), Green(0.14mm,6"X5.5M), Black(0.14mm,6"X5.5M), Pink(0.14mm,6"X5.5M), Yellow(0.14mm,6"X5.5M), Red(0.14mm,6"X5.5M), Orange(0.14mm,6"X5.5M), Blue(0.18mm,6"X5.5M), Green(0.18mm,6"X5.5M), Black(0.18mm,6"X5.5M), Pink(0.18mm,6"X5.5M), Yellow(0.18mm,6"X5.5M), Red(0.18mm,6"X5.5M), Orange(0.18mm,6"X5.5M), Blue(0.22mm,6"X5.5M), Green(0.22mm,6"X5.5M), Black(0.22mm,6"X5.5M), Pink(0.22mm,6"X5.5M), Yellow(0.22mm,6"X5.5M), Red(0.22mm,6"X5.5M), Orange(0.22mm,6"X5.5M), Blue(0.26mm,6"X5.5M), Green(0.26mm,6"X5.5M), Black(0.26mm,6"X5.5M), Pink(0.26mm,6"X5.5M), Yellow(0.26mm,6"X5.5M), Red(0.26mm,6"X5.5M), Orange(0.26mm,6"X5.5M), Blue(0.14mm,5"X50M), Green(0.14mm,5"X50M), Black(0.14mm,5"X50M), Pink(0.14mm,5"X50M), Yellow(0.14mm,5"X50M), Red(0.14mm,5"X50M), Orange(0.14mm,5"X50M), Blue(0.18mm,5"X50M), Green(0.18mm,5"X50M), Black(0.18mm,5"X50M), Pink(0.18mm,5"X50M), Yellow(0.18mm,5"X50M), Red(0.18mm,5"X50M), Orange(0.18mm,5"X50M), Blue(0.22mm,5"X50M), Green(0.22mm,5"X50M), Black(0.22mm,5"X50M), Pink(0.22mm,5"X50M), Yellow(0.22mm,5"X50M), Red(0.22mm,5"X50M), Orange(0.22mm,5"X50M), Blue(0.26mm,5"X50M), Green(0.26mm,5"X50M), Black(0.26mm,5"X50M), Pink(0.26mm,5"X50M), Yellow(0.26mm,5"X50M), Red(0.26mm,5"X50M), Orange(0.26mm,5"X50M), Blue(0.14mm,6"X50M), Green(0.14mm,6"X50M), Black(0.14mm,6"X50M), Pink(0.14mm,6"X50M), Yellow(0.14mm,6"X50M), Red(0.14mm,6"X50M), Orange(0.14mm,6"X50M), Blue(0.18mm,6"X50M), Green(0.18mm,6"X50M), Black(0.18mm,6"X50M), Pink(0.18mm,6"X50M), Yellow(0.18mm,6"X50M), Red(0.18mm,6"X50M), Orange(0.18mm,6"X50M), Blue(0.22mm,6"X50M), Green(0.22mm,6"X50M), Black(0.22mm,6"X50M), Pink(0.22mm,6"X50M), Yellow(0.22mm,6"X50M), Red(0.22mm,6"X50M), Orange(0.22mm,6"X50M), Blue(0.26mm,6"X50M), Green(0.26mm,6"X50M), Black(0.26mm,6"X50M), Pink(0.26mm,6"X50M), Yellow(0.26mm,6"X50M), Red(0.26mm,6"X50M), Orange(0.26mm,6"X50M) |
| 产品描述 | 橡皮障为弹性薄片状器械，由天然乳胶材料和酞菁化合物染料制成。该产品为非无菌提供。使用前由使用机构根据说明书进行消毒。 |
| 预期用途 | 橡皮障用于牙科治疗时隔离牙齿，配套器械用于配合、辅助橡皮障的施用。 |
| 备注 | \ |
| 备案单位 | 深圳市市场监督管理局 |
| 备案日期 | 2024-05-22 |
| 变更情况 | 2024年5月22日：生产地址由“广东省惠州市惠城区水口街道岃洛六路6号第五栋301A号房（委托深圳市乐捷医疗器械有限公司惠州市分公司生产）”变更为“广东省惠州市惠城区水口街道岃洛六路6号第五栋101、201、801房（委托惠州市德嘉医疗科技有限公司生产）”；受托方企业信息由“受托方企业名称：深圳市乐捷医疗器械有限公司惠州市分公司，受托方统一社会信用代码：91441302MACFBL8L2R”变更为“受托方企业名称：惠州市德嘉医疗科技有限公司，受托方统一社会信用代码：91441302MACBEPQK26”。 |
| 备案类型 | 国产 |
深圳市乐捷医疗器械有限公司备案的橡皮障（备案号：粤深械备20240117号）
，橡皮障为弹性薄片状器械，由天然乳胶材料和酞菁化合物染料制成。该产品为非无菌提供。使用前由使用机构根据说明书进行消毒。 橡皮障用于牙科治疗时隔离牙齿，配套器械用于配合、辅助橡皮障的施用。
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