Number of Production Licence: Number of Production Licence of Jiangsu FDA is 2010-0270
Number of Registered Certificate:15041892 001
Operative Standard:EN ISO 13485:2012+AC:2012, MDD 93/42/EEC Annex II
Expected Usage:Application for skin suture in operation room and emergency.
Characteristics: The raw material of Disposable Skin Stapler has no side effects to human body. Easy to operate, stitching quickly with smooth wound, shorten time for operation, reduce bleeding and improve the quality of skin suture.
Using Instructions 1. Using Instructions of Disposable Skin Stapler: 1) To clean the skin of wound and incision for operation and hold the skin stapler in hand to keep the skin stapler is vertical to the skin and make sure the incision is in the middle of the stapler pin and then press to the skin. 2) Hold tightly the movable handle until the stapler pins finish the suture of the skin. (The handle must be pressed until the operation is finished and it can't be loosen during suturing period) 3) Loosen the movable handle and to take suture site as the center to lift the end of stapler by anticlockwise to withdraw the stapler. 4) To repeat the operation above for the residual suturing operation to finish the skin suture of the trauma or incision 2.Using Instructions of the Remover of Disposable Skin Stapler: 1) CSPF-W type of disposable skin stapler matches with CSPF-CW type of remover of skin stapler; CSPF-R type of disposable skin stapler matches with CSPF-CR type of remover of skin stapler. 2) To put the two parallel grapnels of the remover between the stapler pin and skin tissue and hold the remover tightly to remove the stapler pin from the skin tissue. 3) Remover of skin stapler (optional) is re-using product; it's unsterilized before leaving the factory, for clinical use please after conventional disinfection.
Points of Attention 1) Disposable skin stapler is not suitable for the incision of the operation, which is required for docimasia after operation. 2) It is prohibited to use the disposable skin stapler when the distance between skin incision and interior tissue is less than 5mm. 3) It is prohibited to use the disposable skin stapler in suture of interior tissues. 4) The product is prohibited to use when the package is broken. 5) The product is prohibited to use when it exceed the valid date. 6) The product is sterilized and discard for single use, repeat use is prohibited. 7) The operation doctor should be trained. Package Individual disposable skin stapler is packed by blister packing and remover is packed by medical Paper/PE bag .The middle and outer package is corrugated box.
Storage The products should be stored in less than 80% relative humidity, non-corrosive gases and well-ventilated room.
Description of Label 1. For single use
2. The product is EO sterilized
Sterile Model:EO sterilization Validated period of Sterilization:Three years Manufacturing Company:Changzhou Medical Bioengineering Co., Ltd Address:Tianzhutang, Dongqing, Zhenglu Town, Wujin District, Changzhou City, 213114, China Post Code:213114 Tel:86-519-88966750 Fax:86-519-88964890 Website:www.china-changsheng.com EU Representative: Shanghai International Holding Corp. GmbH (Europe) JIN LIANG Address:Eiffestrasse 80, 20537 Hamburg, Germany