Rechtliche Angaben
ECLIPSE 2L is a double lumen balloon catheter intended for use in the peripheral vasculature and neurovasculature for temporary occlusion. The balloon catheters provide temporary vascular occlusion which is useful in selectively stopping or controlling blood flow and for the vasospasm treatment. The balloon catheters also offer balloon assisted embolization of intracranial aneurysms. They are also indicated for use in the peripheral vasculature and neurovasculature for administration of diagnostic agents (contrast solution) and therapeutic agents (embolization materials compatible with the inner diameter of the balloon catheters ECLIPSE 2L). Class III CE0297 in compliance with Medical Device Directive (MDD 93/42/EEC amended by 2007/47/EC). Manufactured by BALT Extrusion. Carefully read the instructions for use before use. First CE marking:2014.The content of this document, in particular data, information, trademarks and logos are BALT SAS’s sole property. © 2018 year BALT and its affiliates, all rights reserved. All representation and/or reproduction, whether in part or in full, is forbidden and would be considered a violation of BALT SAS and its affiliates’ copyrights and other intellectual proprietary rights. This document with associated pictures are non-contractual and are solely dedicated to healthcare professionals and BALT’s distributors (BALT’s supplier’s distributors). The products commercialized by BALT SAS shall exclusively be used in accordance with the instructions for use included in the boxes. DC035GB (08/18)
The COPERNIC 2L double lumen balloon catheters are intended for use in the peripheral vasculature and neurovasculature for temporary occlusion. The balloon catheters provide temporary vascular occlusion which is useful in selectively stopping or controlling blood fl ow and for the vasospasm treatment. The balloon catheters also offer balloon assisted embolization of intracranial aneurysms. They are also indicated for use in the peripheral vasculature and neurovasculature for administration of diagnostic agents (contrast solution) and therapeutic agents (embolization materials compatible with the inner diameter of the balloon catheters COPERNIC 2L). The content of this document, in particular data, information, trademarks and logos are BALT S.A.S and affi liates’ sole property. Consequently, all representation and/ or reproduction, whether in part or in full, is forbidden and would be considered a violation of BALT S.A.S and affi liates’ copyrights and other intellectual proprietary rights ©2017 BALT S.A.S and affi liates all rights reserved. This document with associated pictures are non-contractual and are solely dedicated to healthcare professionals and BALT S.A.S and affi liates’ distributors. The products commercialized by BALT SASand affi liates shall exclusively be used in accordance with the package inserts which have beenupdated and included in the boxes. COPERNIC 2L is class III CE marked (LNE/G-MedCE0459) according to the Medical Device Directive 93/42/EEC since 2014.DC036GB (06/2017)
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