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RESTORE DEB Paclitaxel Releasing PTCA Balloon Catheter紫杉醇释放冠脉球囊扩张导管
| Brand | CARDIONOVUM（凯德诺） |
|---|---|
| Manufacturer | CARDIONOVUM GmbH德国凯德诺有限责任公司 |
| Production Address | Am Bonner Bogen2，53227 Bonn，Germany |
| Intended Use | This product is used for the treatment of in-stent restenosis in the coronary artery. It is also used for the treatment of primary coronary artery lesions with a vessel diameter ≥2.25mm and ≤2.75mm. The 2.0mm balloon diameter product can be used for the treatment of primary coronary artery lesions with a vessel diameter ≥2.00mm and ＜2.25mm.该产品用于冠状动脉支架内再狭窄病变治疗；用于血管直径≥2.25mm且≤2.75mm的原发冠状动脉血管病变治疗；球囊直径2.0mm产品可用于血管直径≥2.00mm且＜2.25mm的原发冠状动脉血管病变治疗。 |
| References | R2.00-15，R2.00-20，R2.50-20，R2.25-25 ……… |
| Manufacturer’s Website | https://cardionovum.de/restore/ |
| Product Brochure | |
| Registration Certificate | 国械注进20193030495 |
Brand
The product is made of an Rx type balloon dilation catheter coated with a drug coating. The drug coating consists of paclitaxel and paclitaxel hydrochloride. The paclitaxel dosage density is 3.0μg/mm2. The product is sterilized with ethylene oxide and is for single-use only. The shelf life of the product is two years.
该产品由Rx型球囊扩张导管涂覆药物涂层而成，药物涂层由紫杉醇及紫胶铵盐组成，紫杉醇剂量密度为3.0μg/mm2。产品环氧乙烷灭菌，一次性使用。货架有效期两年。
Product List
| REF | GTIN | Classification Code | Description |
|---|---|---|---|
| R 2.00-15 | 05906190156013 | 03-13-06 | R 2.00-15紫杉醇释放冠脉球囊扩张导管 |
| R 2.00-20 | 05906190156020 | 03-13-06 | R 2.00-20紫杉醇释放冠脉球囊扩张导管 |
| R 2.00-25 | 05906190156037 | 03-13-06 | R 2.00-25紫杉醇释放冠脉球囊扩张导管 |
| R 2.00-30 | 05906190156044 | 03-13-06 | R 2.00-30紫杉醇释放冠脉球囊扩张导管 |
| R 2.25-15 | 05906190156051 | 03-13-06 | R 2.25-15紫杉醇释放冠脉球囊扩张导管 |
| R 2.25-20 | 05906190156068 | 03-13-06 | R 2.25-20紫杉醇释放冠脉球囊扩张导管 |
| R 2.25-25 | 05906190156075 | 03-13-06 | R 2.25-25紫杉醇释放冠脉球囊扩张导管 |
| R 2.25-30 | 05906190156082 | 03-13-06 | R 2.25-30紫杉醇释放冠脉球囊扩张导管 |
| R 2.50-15 | 05906190156099 | 03-13-06 | R 2.50-15紫杉醇释放冠脉球囊扩张导管 |
| R 2.50-20 | 05906190156105 | 03-13-06 | R 2.50-20紫杉醇释放冠脉球囊扩张导管 |
| R 2.50-25 | 05906190156112 | 03-13-06 | R 2.50-25紫杉醇释放冠脉球囊扩张导管 |
| R 2.50-30 | 05906190156129 | 03-13-06 | R 2.50-30紫杉醇释放冠脉球囊扩张导管 |
| R 2.75-15 | 05906190156136 | 03-13-06 | R 2.75-15紫杉醇释放冠脉球囊扩张导管 |
| R 2.75-20 | 05906190156143 | 03-13-06 | R 2.75-20紫杉醇释放冠脉球囊扩张导管 |
| R 2.75-25 | 05906190156150 | 03-13-06 | R 2.75-25紫杉醇释放冠脉球囊扩张导管 |
| R 2.75-30 | 05906190156167 | 03-13-06 | R 2.75-30紫杉醇释放冠脉球囊扩张导管 |
| R 3.00-15 | 05906190156174 | 03-13-06 | R 3.00-15紫杉醇释放冠脉球囊扩张导管 |
| R 3.00-20 | 05906190156181 | 03-13-06 | R 3.00-20紫杉醇释放冠脉球囊扩张导管 |
| R 3.00-25 | 05906190156198 | 03-13-06 | R 3.00-25紫杉醇释放冠脉球囊扩张导管 |
| R 3.00-30 | 05906190156204 | 03-13-06 | R 3.00-30紫杉醇释放冠脉球囊扩张导管 |
| R 3.50-15 | 05906190156211 | 03-13-06 | R 3.50-15紫杉醇释放冠脉球囊扩张导管 |
| R 3.50-20 | 05906190156228 | 03-13-06 | R 3.50-20紫杉醇释放冠脉球囊扩张导管 |
| R 3.50-25 | 05906190156235 | 03-13-06 | R 3.50-25紫杉醇释放冠脉球囊扩张导管 |
| R 3.50-30 | 05906190156242 | 03-13-06 | R 3.50-30紫杉醇释放冠脉球囊扩张导管 |
| R 4.00-15 | 05906190156259 | 03-13-06 | R 4.00-15紫杉醇释放冠脉球囊扩张导管 |
| R 4.00-20 | 05906190156266 | 03-13-06 | R 4.00-20紫杉醇释放冠脉球囊扩张导管 |
| R 4.00-25 | 05906190156273 | 03-13-06 | R 4.00-25紫杉醇释放冠脉球囊扩张导管 |
| R 4.00-30 | 05906190156280 | 03-13-06 | R 4.00-30紫杉醇释放冠脉球囊扩张导管 |
| Risk-Based Classification风险管理类别 | |
|---|---|
| Product Status产品状态 | Active |
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