Hydrocephalus Management Products - Integra LifeSciences

Hydrocephalus Management ProductsMagnetic Resonance Imaging (MRI) Safety Bulletin For Selected Integra NeurosurgeryCerebrospinal Fluid (CSF) Management ProductsMR SAFEThe Integra Neurosurgery products listed below are MR SAFE in MR enviroments upto 3.0 T (Tesla).This information applies to the following Integra products only:LPVII Valve SystemsNovus Valve SystemsMulti Purpose On-Off Valve SystemsMishler Valve SystemsPudenz Valve SystemsUltraVS Valve SystemsOne Piece Shunt Valve SystemsEdwards-Barbaro ShuntSpecified CathetersSpecified ReservoirsSpecified ConnectorsSpecified Anti-Siphon DeviceMagnetic Resonance Imaging (MRI) Safety InformationThe products listed within this safety bulletin are comprised of one or more of the following implanted materials only: siliconeelastomer, barium sulfate, epoxy, polypropylene, nylon, tantalum/silicone blend used for radio-opaque markings, and/or silicone ink.These products and materials (as used in these products) have been determined to be safe for use in MR environments up to 3.0T(Tesla). For further information regarding this determination, call Integra customer service.Warning:Some kits contain non-implanted accessories used for purposes such as implantation (e.g. stainless steel ventricular stylet, Touhy needle,guidewire, etc.). These accessories must not enter the MR environment as serious injury or death can occur to the patient or clinician dueto missile effect.The Following Products (listed by catalog number) are MR SAFE.LPV II Valve SystemsCatalog NumbersNL8509810 NL8509830 NL8509850NL8509811 NL8509831 NL8509851NL8509820 NL8509840 NL8509860NL8509821 NL8509841 NL8509861Novus Valve SystemCatalog NumbersNL8509010 NL8509021 NL8509610NL8509011 NL8509311 NL8509620NL8509020 NL8509321Multi Purpose Valve SystemCatalog NumbersNL8500108 NL8500125 NL8500128Mishler Valve SystemCatalog NumbersNL8500311 NL8500313 NL8500315NL8500312 NL8500314Pudenz Valve SystemCatalog NumbersNL8501330 NL8501358 NL8501411NL8501331 NL8501359 NL8501412NL8501356 NL8501410 NL8501413NL8501357 NL8501414 NL8501415(MR SAFE Products by catalog number continued on next page)

The Following Products (listed by catalog number) are MR SAFE.UltraVS Valve SystemsCatalog NumbersNL8501109 NL8501115 NL8501127NL8501110 NL8501123 NL8501128NL8501111 NL8501124 NL8501129NL8501113 NL8501125 NL8501130NL8501114 NL8501126 NL8501131One Piece Shunt SystemsCatalog NumbersNL8506102 NL8506302 NL8506403NL8506201 NL8506401 NL8506501NL8506202 NL8506402CathetersCatalog NumbersNL8501200 NL8501376 NL8501328NL8501201 NL8501380 NL8501515NL8501202 NL8501381 NL8501517NL8501220 NL8501382 NL8501519NL8501221 NL8501228 NL8501390NL8501222 NL8501504 NL8501391NL8501375 NL8501229 NL8501392NL8501415ReservoirsCatalog NumbersNL8501210 NL8501214 NL8501121NL8501211 NL8501215 NL8501132NL8501212 NL8500150 NL8501192NL8501213 NL8500155 NL8501195ConnectorsCatalog NumbersNL8501902 NL8501911 NL8501913NL8501908 NL8501919 NL8501900Anti-Siphon DeviceCatalog NumberNL8500200MR Safety Customer Bulletin: Integra Hydrocephalus Management ProductsIntegra 311 Enterprise Drive, Plainsboro, NJ 08536nUSA and Canada: 800.997.4868 609.936.5400 (Outside USA)n888.980.7742 (Fax)integralife.comLPVII, NOVUS, Mishler, UltraVS, Integra and the Integra logo are trademarks of Integra LifeSciencesCorporation. ©2011 Integra LifeSciences Corporation. All rights reserved. Printed in the USA. NS4156-08/10