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Angio-Seal™ VIP Vascular Closure Device血管封合器
| Brand | Terumo（泰尔茂） |
|---|---|
| Manufacturer | Terumo Medical Corporation泰尔茂医疗有限公司 |
| Production Address | 14901 DeVeau Place Minnetonka, MN 55345-2126 USA; Lot 20-B St.,Caguas,Puerto Rico 00725 |
| Intended Use | This product is suitable for closure of femoral artery access site after arterial puncture.该产品适用于闭合因动脉穿刺操作而引起的股动脉开口。 |
| References | 610132， 610133 ……… |
| Manufacturer’s Website | https://www.terumo-europe.com/en-emea/products/angio-seal™-vip-vascular-closure-device |
| Product Brochure | |
| Registration Certificate | 国械注进20143136146 |
Brand
The product consists of Angio-seal device, sheath introducer, dilator locator, and guidewire. The Angio-seal device is composed of an anchor block (polyisoprene-polyethylene copolymer), a collagen hemostatic sponge (bovine collagen), a suture (polyethylene glycol with polycaprolactone/polyethylene glycol copolymer coating), a compression tube, a loading tube, and a device cover. The product is sterilized by radiation and is for single-use. The product has a shelf life of 1 year.
该产品由Angio-seal装置、导管鞘、扩张定位器、导丝组成。Angio-seal装置由固定块（丙交酯乙交酯聚合物）、止血胶原海绵（牛胶原）、缝线（聚乙醇酸，带有聚己内酯/聚乙醇酸共聚物涂层）、塞压管、装载管、装置盖等组成，产品经辐射灭菌，一次性使用。产品货架有效期1年。
| Risk-Based Classification风险管理类别 | |
|---|---|
| Product Status产品状态 | Active |
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