Country: Belarus
Language: Russian
Source: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Boston Scientific Corporation, СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ
изделия медицинского назначения
Boston Scientific Corporation
2020-05-28
50502703-01 INSTRUCCIONES DE USO 6 MODE D’EMPLOI 10 GEBRAUCHSANWEISUNG 14 ISTRUZIONI PER L’USO 18 GEBRUIKSAANWIJZING 22 INSTRUÇÕES DE UTILIZAÇÃO 26 Boston Scientific (DFU Template 3in x 9in Global, 91031819AA), DFU, MB, Contour VL, Global, 50502703-01B Black (K) ∆E ≤5.0 DIRECTIONS FOR USE 2 2019-10 CONTOUR VL ™ Variable Length Percuflex ™ Stent with HydroPlus ™ Coating 2 Boston Scientific (DFU Template 3in x 9in Global, 91031819AA), DFU, MB, Contour VL, Global, 50502703-01B Black (K) ∆E ≤5.0 Black (K) ∆E ≤5.0 ONLY CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. WARNING Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative. For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy. DEVICE DESCRIPTION The Contour Variable Length Stent is designed to be placed over a guidewire to help drain urine from the kidney into the bladder. The coils on both distal and proximal pigtails allow one stent to be used in adult ureters of various lengths. This device is coated with exclusive HydroPlus Hydrophilic coating which, when activated, significantly increases the lubricous characteristics of the device. Care should be exercised when handling this coated device (See “Prior to Placement” and “Activate Coating”). C Read the complete document