Shape Memory Medical, Inc., www.shapemem.com. BOSTON SCIENTIFIC - GALWAY PLACEHIT¿ BILIARY WALLSTENT¿ STENT, CAROTID Back to Search Results Model Number H965SCH650750 Device Problems Stent … The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. AccessGUDID - WALLSTENT™ BILIARY (08714729229872)- Endoscopic Biliary Endoprosthesis. Boston Scientific widmet sich der Transformation von Leben durch innovative medizinische Lösungen, die die Gesundheit der Patienten auf der ganzen Welt verbessert. Boston Scientific Carotid WALLSTENT® Found Safe in Study of High Surgical Risk Patients in Routine Clinical Practice. 1.5,3: Conditional 5 More... Coils, Filters, Stents, and Grafts More... De La Cruz Fluoroplastic, Platinum, Piston Otologic Implant Medtronic Xomed, Jacksonville, T. 3: Conditional 5 More... Otologic Implants More... Deck Scraper 45*300-mm Newmatic Medical, www.newmaticmedical.com . Indications:  1 = Tracheobronchial, 2 = Transjugular Intrahepatic Portosystemic Shunt (TIPS), 3 = Transhepatic Biliary, 4 = Iliac, 5 = Venous, Fully open dimensions:  to determine implanted length, refer to Box Label. AccessGUDID - WALLSTENT™ RX BILIARY (08714729296874)- RX Biliary Endoprosthesis Stent System. An office chair was in the wrong place - at ANY time! October 6, 2009 - Boston Scientific Corp. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its WallFlex Biliary RX fully and partially covered stents for the palliative treatment of malignant bile duct strictures. The covered Wallstent was inserted after unresectability was confirmed. $150.00. About Boston Scientific . '�s�.��K ��9YY��� Q'ʮ�Pm�b���p'B� rn��S��|��kh�j���/�3 E�_w}v[�� �}�\�_�/Zu^�|���8�0s5���Ƅ�x �9AJp�e\;�����Y��p�.�3�?י�JQ�չ��gi:�E���\������,�r��>�~UOz�Hy0á ���ȍ�шo�H-�2��qB鬊K^�)m�Ξe�J����9����Y�DnGZ�6NE�Q�i8&������=�U�^�� Go��k��+]%�x���^���6�c�����r���*��;V)�����"�!�R|�0�P�Q��lj(E�H{��g�=�)]QG���T�}ZG�hoz�<0s�06���Vz�•�o��xG��8��Ť�^=�Hm_�O6V�a���kk�]�p5s���/����6�RQ䵔 "��(?q�V�?���*����My�.��_��̔P��Y�&. $150.00) OEM: Boston Scientific; Model #: 6981; Year: 2016 Size: 10mm x 100mm Current Stock: This item is out of stock. Exclusion zone. Skip to Main Content ; U.S. National Library of Medicine NLM Tools and Resources FDA UDI Home FDA Medical Devices Home Report a Device Problem (MedWatch) Device Recalls Device Safety Communications Home; About; News; Download; API; Help; Customer Support & FAQ; FDA Tools and … Platinum Chromium Coronary Stent System . BOSTON SCIENTIFIC - GALWAY WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS 6961-6972 INCLUSIVE CATHETER, BILIARY, DIAGNOSTIC Back to Search Results Model Number UNK384 Section 6.11 Magnetic Resonance Imaging (MRI) Safety Information . endstream endobj 3137 0 obj <>stream The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Below is an excerpt of Section 6.11 from the Directions for Use detailing the safety of performing MRI following the placement of a Promus PREMIER Stent. INDICATIONS: Tracheobronchial: 5–24 mm stents; Transhepatic Biliary: 8–12 mm stents; TIPS: 10–12 mm stents; Central Venous: 10–16 mm stents Fully Open Dimensions (as labeled on box) Approximate Implanted Stent Length Sheath Compatability Diameter* x Length (mm) Lumen Diameter (mm) Stent Length (mm) Lumen Diameter (mm) Stent … $150.00. The safety and effectiveness of the WallFlex Biliary RX Stenting System for use in the vascular system have not been established. Refer to DFU sizing chart for more information. EMBLEM™ MRI S-ICD System; Spinal Cord Stimulation; Transcatheter Aortic Valve Replacement (TAVR) WATCHMAN™ Implant; All Procedures & Treatments; Patient Support; Patient and Caregiver Support; Find A Heart Specialist; Traveling with LATITUDE; Medical Device ID Cards - Pacemaker, ICD, & CRT devices; Find a TheraSphere Treatment Center The safety and effectiveness of the WallFlex Biliary RX Stenting System for use in the vascular system have not been established. WALLSTENT and HALO are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. All rights reserved. NATICK, Mass. Brand Name: WALLSTENT RX BILIARY Version or Model: M00569650 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION What MRI safety Boston Scienti˜c, (Master Brand DFU Template 8.2677in x 11.6929in A4, 92238519A), eDFU, MB, VENOUS WALLSTENT, en 50607601-01B Black (K) ˚E ˛5.0 VENOUS WALLSTENT Self-Expanding Stent 2020-03 < … Brand Name: WALLSTENT® Endoprosthesis Version or Model: H965403330 Commercial Distribution Status: In Commercial Distribution Catalog Number: H965403330 What MRI safety information does the labeling They continue to innovate in these areas and are extending their innovations into new geographies and high-growth adjacency markets. RESONATE IS1 CRTD (G424) Field strength. The •|=gTO^���H��I��H�(x��Z�l�g�v����P�>�姫��4=1��T���$a�̀���ơ;���h�l�[�ba��O����3�I�ٱ�.�H �U�J������*W��9])r��`�]]�i?�u��ۅP���>A�K�p�� #�x��?����Օ���\�(�c�������yBj�d���DH�t�Pp��< QU���8���b�YB������1�'澨3I4y̯�� /�S�3f�LD���4��T�q-w4k�X�I�T�w��. Stryker. It may be a mesh structure or a continuous tube and is made entirely of metal [e.g., high-grade stainless steel, cobalt-chrome (Co-Cr), nickel-titanium alloy (Nitinol)]. AccessGUDID - WALLSTENT™ BILIARY (08714729204664)- Endoscopic Biliary Endoprosthesis. Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210: Code Information : Lot 22960201: Recalling Firm/ Manufacturer: Boston Scientific Corporation 300 Boston Scientific Way Marlborough MA 01752-1291: For Additional Information Contact: Nicole Pshon 763-494-1133 Manufacturer Reason for Recall: The sterile barrier may contain packaging … TrelliX Embolic Coil System, All Versions Shape Memory Medical, Inc., www.shapemem.com MRI Safety Information Non-clinical testing and MRI simulations were performed to evaluate the entire family (i. Model #: 7233 Epic Biliary Endoscopic Stent Systems - 10mm x 80mm. Intended Use/Indications for Use: The WallFlex Biliary RX Stents are indicated for use in the palliative Boston Scientific, www.bostonscientific.com 1.5, 3 Conditional 5 More... Coils, Filters, Stents, and Grafts More... iForma orthopedic implant CONFORMIS, Inc. Lexington, MA … MRI Safe: The Wallstent Venous Endoprosthesis has shown no deflection or torque in the area of maximum spatial gradient (450 gauss centimeter) of a 1.5 tesla MRI system under conditions that produced a Specific Absorption Rate (SAR) of 1.3 W/kg. 880 MRI AccessGUDID - WALLSTENT® Endoprosthesis (08714729204053)- Self-Expanding Stent. Thursday, 07 January 2021 . Purpose . Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB Top *Please note that reconstrainment and repositioning are subject to specific limitation. Boston Scientific Corporation and Stryker Neurovascular, www.stryker.com . 1,5T full body 3T full body. In combinaison with Boston Scientific compatible MRI leads. The Wallstent Self-Expanding Stent has been engineered to combine a unique stent design with a minimal free cell area, and a highly flexible, intuitive delivery system. – BOSTON SCIENTIFIC WALLSTENT Endoprosthesis: 13.3% (4/30) – 3 peritoneal irritation, 1 self limited biliary hemorrhage Conclusions “In conclusion, Viabil [GORE ® VIABIL Biliary Endoprosthesis] stents have been shown to be safe for palliation of malignant Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Products ... Non‐clinical testing has demonstrated that WALLSTENT™ Transhepatic Biliary is MR Conditional for single and overlapping lengths up to 94 mm. AccessGUDID - WALLSTENT™ BILIARY (08714729204640)- Endoscopic Biliary Endoprosthesis. Designed to provide excellent compression resistance, WALLSTENT™ Endoprosthesis Stent provides increased scaffolding for optimal lesion coverage. Four radiopaque marker bands on the Unistep Plus delivery … About Boston Scientific Boston Scientific is a worldwide developer, manufacturer and marketer of Promus ELITE™ Everolimus-Eluting . Double Open Ended Wrench 5.5*7-mm Newmatic Medical, www.newmaticmedical.com . Skip to Main Content ; U.S. National Library of Medicine NLM Tools and Resources FDA UDI Home FDA Medical Devices Home Report a Device Problem (MedWatch) Device Recalls Device Safety Communications Home; About; News; Download; API; Help; Customer Support & FAQ; FDA Tools and Resources FDA … Below is an excerpt of Section 6.12 from the Directions for Use detailing the safety of performing MRI following the placement of a Promus ELITE™ Stent. Hardbound MRI Textbook. *Available sizes vary per indication. MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than forty internationally respected experts in the field. Listing a study does not mean it has been evaluated by the … Carotid WALLSTENT™ & WALLGRAFT™ Endoprostheses. 3136 0 obj <>stream Skip to Main Content ; U.S. National Library of Medicine NLM Tools and Resources FDA UDI Home FDA Medical Devices Home Report a Device Problem (MedWatch) Device Recalls Device Safety Communications Home; About; News; Download; API; Help; Customer Support & FAQ; FDA Tools and … 1.5: Safe More... Orthopedic Implants, Materials, and Devices More... corVCD (implant for vessel coupling) corLife GBR, www.corlife.eu. Boston Scientific Boston Scientific’s products and technologies are used to diagnose or treat a wide range of medical conditions, including heart, digestive, pulmonary, vascular, urological, women’s health, and chronic pain conditions. GMDN Preferred Term Name GMDN Definition; Bare-metal biliary stent A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Das Precision Montage™ MRI SCS-System bietet sicheren Zugang zu Ganzkörper-MRT-Scans, wenn es mit bestimmten Komponenten verwendet und unter den in den ImageReady MRT Ganzkörperrichtlinien für Precision Montage MRT Rückenmarksstimulatorsystem definierten Bedingungen der MRT-Umgebung ausgesetzt wird. A steel oxygen tank is never permitted inside of the MRI system room. IFuse Implant, L Implant including multiple implant configurations with 2 to 4 implants, SI-BONE, www.si-bone.comSI Bone, www.si-bone.com ©2021 Boston Scientific Corporation oder ihre Tochtergesellschaften. The delivery system is braided and offers excellent trackability and pushability More ... 1.5, 3: Conditional 8 More... Coils, Filters, Stents, and Grafts More... 2D Helical, 35 Fibered Platinum Coil. The Wallstent Endoprosthesis Stent has been engineered to combine a unique stent design with a minimal free cell area, and a highly flexible, intuitive delivery system. Summary of Preclinical Studies 9.1 Biocompatibility The biocompatibility of the WALLSTENT Venous BOSTON SCIENTIFIC - GALWAY WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM CATHETER, BILIARY, DIAGNOSTIC Back to Search Results Model Number H965404120 Safety Topic / Subject Double Open Ended Wrench 18*19-mm Newmatic Medical, www.newmaticmedical.com . 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