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Neuroform Atlas Stent System颅内支架系统
| Brand | Stryker（史赛克） |
|---|---|
| Manufacturer | Stryker Neurovascular史赛克神经介入 |
| Production Address | Business & Technology Park, Model Farm Road, Cork, Ireland |
| Intended Use | The intracranial stent system is suitable for patients aged ≥ 18 with intracranial aneurysms. It is used as an adjunct to coil embolization for saccular wide-necked aneurysms (with a neck ≥ 4 mm or a dome/neck ratio < 2) located in the anterior circulation. The diameter of the parent artery carrying the aneurysm should be ≥ 2.0 mm and ≤ 4.5 mm.颅内支架系统适用于≥ 18岁的颅内动脉瘤患者，辅助弹簧圈治疗囊状宽颈（瘤颈≥ 4 mm或瘤体/瘤颈比< 2）动脉瘤，动脉瘤位于前循环血管，载瘤血管直径为≥2.0mm且≤4.5mm。 |
| References | M003EZAS30210， M003EZAS40210，M003EZAS30150 ……… |
| Manufacturer’s Website | https://www.strykerneurovascular.com/us/products/hemorrhagic/neuroform-atlas-stent-system |
| Product Brochure | |
| Registration Certificate | 国械注进20203130290 |
Brand
The product consists of a self-expanding stent, a delivery wire, and a guiding sheath. It comes with a torque device as an accessory. The stent is a self-expanding, open-cell nickel-titanium alloy stent with three radiopaque markers at the proximal and distal ends. The delivery wire for the stent comes in two types: one with a distal tip and one without. The stent is pre-loaded on the delivery wire and protected by a guiding sheath. The product is sterilized with ethylene oxide and is for single use only. The sterilization shelf life is 5 years.
该产品由自扩张支架、递送导丝及导引鞘组成，附件配有扭矩装置一个。该支架是一个自扩张、开孔式开放环镍钛合金支架，近端和远端各带有三个不透射线标记带。支架递送导丝分为有远端尖端和没有远端尖端两种。支架已预装在支架递送导丝上，并带有一个起保护作用的导管鞘。该产品为环氧乙烷灭菌，一次性使用。灭菌有效期为5年。
Product List
| REF | GTIN | Classification Code | Description |
|---|---|---|---|
| M003EZAS45210 | 07613252655985 | 13-06-06 | NEUROFORM ATLAS 4.5MM X 21MM NO TIP - CE |
| M003EZAS30210 | 07613252655909 | 13-06-06 | NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CE |
| M003EZAS40210 | 07613252655923 | 13-06-06 | NEUROFORM ATLAS 4.0MM X 21MM NO TIP - CE |
| M003EZAS45150 | 07613252655978 | 13-06-06 | NEUROFORM ATLAS 4.5MM X 15MM NO TIP - CE |
| M003EZAS40300 | 07613252655961 | 13-06-06 | NEUROFORM ATLAS 4.0MM X 30MM NO TIP - CE |
| M003EZAS40150 | 07613252655954 | 13-06-06 | NEUROFORM ATLAS 4.0MM X 15MM NO TIP - CE |
| M003EZAS30150 | 07613252655879 | 13-06-06 | NEUROFORM ATLAS 3.0MM X 15MM NO TIP - CE |
| M003EZAS45300 | 07613252656036 | 13-06-06 | NEUROFORM ATLAS 4.5MM X 30MM NO TIP - CE |
| M003EZAS40240 | 07613252655930 | 13-06-06 | NEUROFORM ATLAS 4.0MM X 24MM NO TIP - CE |
| M003EZAS30240 | 07613252655916 | 13-06-06 | NEUROFORM ATLAS 3.0MM X 24MM NO TIP - CE |
| Risk-Based Classification风险管理类别 | |
|---|---|
| Product Status产品状态 | Active |
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