35 Filename Date Time UC200xxxxxx EN 4.625″ x 6.0″ inches (117 mm x 152 mm) Medtronic Confidential PPManual.xsl - PatientProgrammerTemplate.fm Version: … Purpose . This tool will provide results only for current CRHF implantable IPG, ICD and CRT devices and leads. BURSTDR™ STIMULATION DELIVERS CONSISTENT, POSITIVE RESULTS 1-2,5-19,21,23-25. MRI Resources Medical device manufacturers insist spinal-cord stimulators are safe ... 57, had three Medtronic spinal-cord implants between 2003 and 2007 after a car accident mangled his back. Analgesic spinal cord electrical stimulation system (1) Analgesic spinal cord electrical stimulation system pulse generator, implantable (1) FDA Product Code Name. You may choose to re-enter your serial number, or contact Medtronic at one of the … The aim was to discuss the perioperative evaluation and management of patients with spinal cord stimulator implants. RestoreUltra Spinal Cord Neurostimulator (RestoreUltra, Model 37712) Models: Itrel 3: 7425 Restore: 37711 Synergy: 7427 SynergyPlus: 7479 Synergy Versitrel: 7427V SynergyCompact: 7479B. Introducing the Intellis⢠platform, a future-focused technology setting the standard for chronic pain management. MRI mode turns stimulation off. Medtronic Spinal Cord Stimulators Are FDA Approved as a Safe and Effective Option for Chronic Pain Relief As an intervention for intractable chronic pain, spinal cord stimulation can be an effective alternative or adjunctive treatment to other therapies that have failed to manage pain on their own. Safety Info ID# Safety Topic / Subject Article Text 255: Bone Fusion (Spinal) Stimulator: The implantable bone fusion or spinal fusion stimulator is designed for use as an adjunct therapy to a spinal fusion procedure. ... (97715). A literature review, summary of ⦠Search by the product name (lntellis) or model number (97715). Read our privacy statement to learn more.
MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF: Back to Search Results: Model Number 97715: Device Problems Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Malposition of Device (2616) Patient Problem Undesired Nerve Stimulation (1980) Event Date 11/24/2020: â¦
Magnetic resonance imaging (MRI).
ImageReady MRI Spinal Cord Stimulator Systems allow patients to safely undergo MRI scans. The FDA considers spinal-cord stimulator … But when you have an implanted device, you have to be careful about MRI scans. Intellis tm Platform for Spinal Cord Stimulation. View online or download Medtronic MyStim 97740 User Manual. Medtronic won FDA approval and is releasing in the U.S. its Intellis spinal cord neurostimulation platform, which includes the worldâs smallest fully implantable spinal cord neurostimulator. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. SPRINT QUATTRO SECURE S MRI 6935M (55, 62 cm) et 6935 (58, 65 cm) Field strength. In combination with Medtronic MRI compatible can. The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI). Approximately 59% to 74% of patients with chronic back and leg pain will need at least one non-spine MRI within 10 years of implant. Changes the signals: The stimulator is placed in the epidural space and it sends an electrical impulse into the back portion of the spinal cord. STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF (2) FDA Product Code Advise the patient to carry the ⦠AccessGUDID - Intellis⢠AdaptiveStim® (00763000315467)- INS 97715 INTELLIS SENSOR US EMANUAL Posted on August 12, 2013 in Alternative Pain Therapy A new type of spinal cord stimulator that is compatible with magnetic resonance imaging (MRI) is now being used in the U.S. to treat chronic back and leg pain. Indications, Safety, and … More ... 1.5: Conditional 5 More... Spinal Cord Stimulation, SureScan MRI Version, Medtronic, Inc. More... Neurostimulation System PrimeAdvanced SureScan MRI⦠152. A steel oxygen tank is never permitted inside of the MRI … view details about intellis⢠BUILT FOR A BETTER FUTURE THAT STARTS TODAY .
Neurostimulation System PrimeAdvanced Spinal Cord Neurostimulator Spinal Cord Stimulation System PrimeAdvanced, Model 37702 Medtronic, Inc. www.Medtronic.com 7 Maintenance. An office chair was in the wrong place - at ANY time! Approximately 82% of SCS-implanted patients will likely need at least one MRI within five years of implant.
Components shown are for use only with the Intellis Platform.) * Under specific conditions and requires SureScan™ MRI … What MRI safety information does the labeling contain? Vicente Martinez-Sanjuan, MD, Vicente Martinez-Sanjuan, MD Magnetic Resonance Department, ⦠The … SureScan MRI System, Only SureScan™ MRI technology — integrated across the entire Medtronic portfolio — provides full-body MRI access* in Normal Operating Mode.†, Only SureScan MRI technology — integrated across the entire Medtronic portfolio — provides full-body MRI access* in Normal Operating Mode.† Scan any SureScan MRI patient as you would a patient without a device.1. medtronic spinal cord stimulator problems. Intellis is the unrivalled spinal cord stimulation platform because it overcomes the limitations of other SCS systems. Intellis™ with AdaptiveStim™ SureScan MRI model 97715; RestoreSensor™ SureScan MRI model 97714 ... MRI Guidelines for Medtronic Neurostimulation Systems for ... Safety, and Warnings. Top answers from doctors based on your search: Disclaimer. Mode of MR operation in which none of the outputs have a value that may cause physiological stress to patients (2 W/kg whole body SAR, 3.2 W/kg head SAR, and up to 80% of the PNS limit). Ask doctors free. Electrocautery is generally not recommended in these patients but sometimes used despite known risks. No claims of safety are made for MRI scans involving modified Medtronic DBS systems or components (eg, custom devices to mitigate allergies) or for non-Medtronic components or accessories. In fact, approximately 82% of patients with an implanted spinal cord stimulation system (SCS) are expected to need at least one MRI within five years of implant. MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF: Back to Search Results: Model Number 97715: Device Problems Energy Output Problem (1431); Malposition of Device (2616); Patient Device Interaction Problem (4001) Patient Problems Pain (1994); Insufficient Information (4580) Event Date 10/16/2020: ⦠Dive Insight: The labels on spinal cord stimulators are clear on the need for trial simulation periods: Materials from Abbott, Boston Scientific, Medtronic and Nevro state their devices are only for use in patients who received effective pain relief during trial stimulation.
ImageReady MRI Spinal Cord Stimulator Systems allow patients to safely undergo MRI scans. Refer to product labeling for list of conditions. Precision Spectra Spinal Cord Stimulator (Stimulation) SCS System with ImageReady MRI Technology Neurostimulator Boston Scientific, www.bostonscientific.com NOTE: The MRI labeling may be different in the. The patient is allowed to have an MRI scan inappropriate for the implanted components, which could cause tissue heating, resulting in tissue damage or serious patient injury. MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF: Back to Search Results: Model Number 97715: Device Problems Unintended Collision (1429); Loss of Power (1475) Patient Problems Fall (1848); Complaint, Ill-Defined (2331) Event Date 07/29/2018: Event Type Malfunction Manufacturer Narrative â¦
The Food and Drug Administration gave Medtronic (NYSE: MDT) approval to use the SureScan device in March ⦠This information can be found on the Patient MRI Form which will be provided by your neurologist. MRI Guidelines for Medtronic Neurostimulation Systems for Chronic Pain, http://manuals.medtronic.com. MRI mode can be activated with your Model 97740 patient programmer or with a clinician programmer (if you have a neurostimulator with SureScan MRI Technology). The neurostimulator also features SureScan™ MRI* and AdaptiveStim™ technology. When you call to make an appointment for an MRI, inform the MRI center that you have an implanted vagus nerve stimulator; Provide the model number of your implanted VNS Therapy device, as well as the name and contact information of your neurologist. Here you will find important information about ImageReady MRI technology, supported devices and conditions for use.
For Neurostimulators with Surescan MRI Technology (Models 97702, 97712, 97713, 97714) 155. For Medtronic neurostimulation systems with SureScan MRI Technology, external control devices (ie, a clinician programmer or a patient control device) are used to determine MRI scan-type eligibility and are used to place the neurostimulation system in MRI conditionally safe (MRI-CS) mode (also referred to as "MRI mode"), which turns stimulation … 1,5T full body 3T full body. Problems associated with this issue are rare and removal of implanted devices in the absence of symptoms is not recommended. Full Body MRI Systems WaveWriter Alpha⢠SCS Systems. This site uses cookies to store information on your computer. MRI GUIDELINES . Filename Date Time Medtronic Confidential UC200xxxxxx EN PPManual.xsl - PatientProgrammerTemplate.fm 4.625″ x 6.0″ inches (117 mm x 152 mm) Template version 6.2: 11-06-2015 Turning stimulation back on after the MRI scan Turn stimulation back on when the MRI scan is complete and you are outside of the MRI … Spinal Cord Stimulation Systems
As with all products, Medtronic monitors for the safety of our products through the post market surveillance process and also reports safety information to regulators as appropriate. USA Rx only Filename Date Time UC200xxxxxx EN 4.625 x 6 inches (117.602 mm x 152.4 mm) Medtronic Confidential IFUBookManual.xsl - IFUBookManual Template version 5.3: 04-17-2013 M939858A007 Rev X ⦠Find MRI guidelines and resources for radiology and other clinicians for our cardiac monitors, implantable cardiac devices, and spinal cord stimulation systems. A Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) as an aid in the management of chronic, intractable pain of the trunk and/or limbs - including unilateral or bilateral pain associated wtih the following conditions: Failed Back Syndrome (FBS) or low back syndrome or failed back How Stimwave's Spinal Cord Stimulator & Peripheral Nerve Stimulator Works - Animated - Duration: 2:11. Table 6.1 shows where to go in this chapter for more information. Inform the patient with a neurostimulation system that stimulation needs to be turned off prior to the MRI scan. 1:46. Displaying 1 - 3 of 3. ImageReady™ MR-Conditional Spinal Cord Stimulator Systems. Floor polishers are poor MRI system cleaners! 97745 medical equipment pdf ⦠Under specific conditions. Intended Use. Safety Topics; Home; help (full/part words) ... PrimeAdvanced SureScan MRI, Model 97702 Spinal Cord Neurostimulator Spinal Cord Stimulation System PrimeAdvanced SureScan MRI, Model 97702 Medtronic, Inc. www.Medtronic.com Imp. Phone 2018 - Medtronic Spinal Stimulator Pain.
In the future, you may need magnetic resonance imaging (MRI) to diagnose an illness. Update my browser now.
Spinal cord stimulation (SCS)-indicated patients are three times more likely to need an MRI than the general population. Healthcare Professionals
Indications, Safety, and Warnings. A prospective in vivo study in patients with SCS, exploring the changes produced by MRI and the associated side effects, was performed. The Medtronic Intellis Model 97715 Neurostimulator is part of a neurostimulation system for pain therapy. The Evolve SM Workflow, running on the Intellis⢠platform, offers standardised ⦠Specific conditions. New Spinal Cord Stimulator Safe For Mri Scans. MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF : Back to Search Results: Model Number 97715: Device Problems Failure to Deliver Energy (1211); Environmental Compatibility Problem (2929) Patient Problems Therapeutic Effects, Unexpected (2099); Discomfort (2330) Event Date 07/29/2020: Event Type ⦠You may at any time change the settings regarding cookies. The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI). (AdaptiveStim™ technology is only available on the Intellis™ model 97715. Medtronic SureScan® MRI - Duration: ... Mark's Hospital 134 views. MEDTRONIC, INC. (2) Brand Name. MRI has not been evaluated with test stimulation components. Indications, Safety, and Warnings ... Spinal Cord Stimulation Healthcare Professionals. ⦠These MRI scans could be requested by a variety of physicians who may not be aware of the implanted device and its ⦠Device Description: INS 97715 INTELLIS SENSOR MRI US EMANUAL CLOSE. A steel oxygen tank is never permitted inside of the MRI system room. We do not recognize this serial number as a Medtronic CRHF device. Unfortunately,spinal-cord stimulator implant recalls are far from rare. The Intellis TM implantable neurostimulator is powered by proprietary Overdrive TM battery technology. View and Download Medtronic 97745 user manual online. MRI mode before your MRI scan. In fact, manufacturers issued more than 50 such recalls since 2005. ¹4DjU½s«3aÑ=ac9¹d_;ÎÿP°foc0ãDæÏX壧h¯S4sf«ÖMiÙµ´³Ùÿ´¤OÕ©9@èTé³ëosºäqÒx#ûÈýEV4½Ò_¹ïøXlìÀâËàÀNNî[¦ÁÚ7göq î6Vä"¿:E#-«òØw°'Sµ`¯«Imà+t%ÂÞ' §N¥ëä>òJÏ©ê÷£NzøÙq¨/vÎçÍi^ø zºöfS'7v×àX÷á5£VrPOäÞnmGﵫõ棺a îG42Ü ùíJqâ©ËP ýpÌï¾I¾ØØÚúCÍ
í®¥IP(»\M~. Last update. In addition, Medtronic chooses to maintain a Product Performance Registry that collects performance and safety data for many ⦠Medtronic won FDA approval and is releasing in the U.S. its Intellis spinal cord neurostimulation platform, which includes the world’s smallest fully implantable spinal cord neurostimulator. Filename Date Time UC200xxxxxx EN 4.6 x 6 inches (117 mm x 152 mm) Intellis™ Medtronic Confidential ImplantManual.xsl - IPGTemplate.fm Template version: 08-02-2011 97715 Rechargeable neurostimulator Implant manual ! Electromagnetic Compatibility Guide for Cardiac Devices, Intellis™ with AdaptiveStim™ SureScan MRI model 97715, RestoreAdvanced™ SureScan MRI model 97713, ACCESS GUIDELINES IN THE MRI MANUALS LIBRARY, Minimally Invasive Therapies (formerly Covidien), Information About Proposition 65 for California Customers, California Transparency in Supply Chains Act, Simplifies future diagnoses and treatment and eases patient concerns, Allows MRI to be performed in Normal Operating Mode, Gives Intellis patients the same unrestricted MRI access as non-implanted patients, Injex™ anchors (for use with percutaneous leads only). By using the site, you consent to the placement of these cookies. Access prescriber, implant, MRI, and other manuals on the Medtronic Manual Library. MRI SCAN ELIGIBILITY CANNOT BE DETERMINED. PubMed.
BurstDR stimulation has not only proven to have superiority over tonic stimulation in a large, randomized, controlled trial, 1 but it has also shown consistent and replicable results across diverse clinical settings around the world for over a … Refer to product labeling for list of conditions. MRI during test stimulation – Explant all test stimulation components if an MRI scan is required. Model(s): SC-1216, SC-1232; Full Body Patient Eligibility Checklist; WaveWriter Alpha⢠Prime SCS Systems. Read this section to gather important prescription and safety information. Requires SureScan MRI implantable neurostimulator and leads. Tuesday, 26 January 2021 . You may choose to re-enter your serial number, or contact Medtronic at one of the numbers below: Information for Healthcare ⦠ó®íõ®kÁïR¹³s:}eõ\¶ÊÖ¹®:øâêübZì¸Æ
Mã£qXlYN×ê JR\¤iâ?Tͦús/Öµa5ËgÁùCöýõå«cëÀYðw,ó The Intellis™ SCS system uses Medtronic SureScan™ MRI technology, giving you the same full-body MRI† access as non-implanted patients — now and in the future. We do not recognize this serial number as a Medtronic CRHF device. Spinal Cord Stimulation Prescription and Safety Information. Home MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF: Back to Search Results: Model Number 97715: Device Problems Electromagnetic Interference (1194); Energy Output Problem (1431); Overheating of Device (1437) Patient Problems Burning Sensation (2146); Increased Sensitivity (4538) Event Date ⦠USING THE PATIENT PROGRAMMER TO ACTIVATE MRI MODE. A 30-year-old member asked: how well does a spinal cord stimulator work? Magnetic resonance imaging (MRI) is considered safe under strict labeling conditions. MRI guidelines for Medtronic neurostimulation systems for chronic pain See "START HERE" section before conducting MRI. 156. No exclusion zone. Understand the conditions under which a patient with a spinal cord stimulation system can undergo an MRI. This tool will provide results only for current CRHF implantable IPG, ICD and CRT devices and leads.
Medtronic Monitors the Safety of Spinal Cord Stimulators. Package contents Neurostimulator Torque wrench Pocket sizer Bore plugs (2) Product literature Registration form Patient identification card Warranty card Patient identification card A patient identification card is packaged with this device. To obtain accurate results, you must enter the serial number accurately. To obtain accurate results, you must enter the serial number accurately.
If the patient brought a patient control device to the MRI appointment, go to "START Understand the conditions under which a patient with a spinal cord stimulation system can undergo an MRI.
Assess other implanted devices - Prior to an MRI examination, determine whether the patient has multiple medical device implants, either active medical device implants (such ⦠Medtronic recommends that you do not conduct an MRI examination of any part of the body on a patient ⦠Device Characteristics. CONTROLLER, Pain therapy for neurostimulation system models 97715, 97716, 97725. MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF: Back to Search Results: Model Number 97715: Device Problems Overheating of Device (1437); Battery Problem (2885); Patient Device Interaction Problem (4001) Patient Problems Increased Sensitivity (2065); Swelling (2091); Burning Sensation (2146); ⦠The safety of performing magnetic resonance imaging (MRI) in patients with spinal cord stimulation (SCS) systems needs to be documented. Accessed December 2017. An office chair was in the wrong place - at ANY time! Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Turning Stimulation Back On After the MRI Scan. The MRI clinician must consult the MRI guidelines to determine how to proceed or contact Medtronic Technical Support at 800-328-0810. 14 English 97715, 97716 2017-06-01 Medtronic MyStim 97740 Pdf User Manuals. Study design. Mode of MR operation in which none of the outputs have a value that may cause physiological stress to patients (2 W/kg whole body SAR, 3.2 W/kg head SAR, and up to 80% of the PNS limit). Physicians should not prescribe MRI for patients undergoing test stimulation or who have any neurostimulation system components that are not fully implanted. The MRI clinician must consult the MRI guidelines for those conditions. Medtronic Australasia has written to health professionals who have implanted spinal cord stimulation models affected by the hazard alert, or are managing patients who have these devices, providing further information.
Floor polishers are poor MRI system cleaners! External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. Approximately half involved Medtronic devices. MR Conditional Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437): ... Analgesic spinal cord electrical stimulation … The patient is unnecessarily restricted from having an MRI scan. MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF: Back to Search Results: Model Number 97715: Device Problems Intermittent Continuity (1121); Energy Output Problem (1431); Electromagnetic Compatibility Problem (2927); Patient Device Interaction Problem (4001) Patient Problems Device ⦠Exclusion zone. Medtronic Spinal Stimulator Pain. MRI-Compatible Spinal Cord Stimulator Device and Related Changes in Patient Safety and Imaging Artifacts Jose De Andres, MD, PhD, FIPP, EDRA, Jose De Andres, MD, PhD, FIPP, EDRA Search for other works by this author on: Oxford Academic. Here you will find important information about ImageReady MRI technology, supported devices and conditions for use. céYYñ8ùÙ¯ßýñí×_¿ýúï~z÷öýã³ß~_}ñù%ß\>û÷/ËñÍ||w\þzä#ù¿|ôy-kuök*ÇÓ;þüÎßxuµ2üÿªÿßû¯küiÍ6å]^ù®µ['5ùãÈê;úÿ¾ÓõºòÀ´k÷ÑíZû:^õëJìj×2DÏÖtÎ
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±!M¾;Ö"ðm§0k»ZcßYM}Û"oÓ]Îãja SPINAL CORD STIMULATION - tamethepain - Spinal cord stimulation, also known as neurostimulation therapy, is an FDA-approved chronic pain therapy shown to be safe and effective for people who have not had success … With an updated browser, you will have a better Medtronic website experience. When you or the patient activate MRI mode with the patient programmer, stimulation is turned off and the In MRI Mode screen will appear, showing the MRI … Search by the product name (lntellis) or model number (97715). ⦠Place the neurostimulation system in MRI mode before the MRI scan and outside of the MRI scanner room. Information for healthcare professionals about the Intellis platform used for spinal cord stimulation and peripheral nerve stimulation for the ... MRI, and other manuals on the Medtronic Manual Library. All patients had neurological deficits and required surgery to remove the mass. Medtronic, Inc. MRI and Neurostimulation Therapy for Chronic Pain . After defibrillation, confirm the neurostimulation system is still working. "how well does a spinal cord stimulator work?" MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF: Back to Search Results: Model Number 97715: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Discomfort (2330) Event Date 01/01/2019: Event Type Injury Manufacturer Narrative If information is ⦠ImageReady™ MRI Full Body Guidelines for Precision Montage™ MRI Spinal Cord Stimulator System 91035972-02 Rev A ii of iv Guarantees Boston Scientific Corporation reserves the right to modify, without … Dr. David Bozak answered. If you have a spinal cord stimulation device implanted and have any qu… MRI COMPATIBILITY. Google Scholar. Have Spinal-Cord Stimulator Systems Undergone Adequate Testing? Medtronic has identified 14 reports over the last 30 years worldwide describing delayed spinal cord compression due to an epidural mass consisting of reactive tissue (granulomatous and/or fibrous tissue) around a Medtronic spinal cord stimulation lead. Intellis⢠AdaptiveStim® (2) GMDN Term.
MRI scan-type eligibility and are used to place the neurostimulation system in MRI mode, which turns stimulation off. * Under specific conditions and requires SureScan⢠MRI implantable neurostimulator and leads. MRI has not been tested on trial (test) stimulation components and may cause heating of the lead electrodes, resulting in tissue damage or serious patient injury. The severity of symptoms ranged from ⦠The companies also provide information on how to carry out these trial periods. Some are essential to make our site work; others help us improve the user experience.
ACCESS GUIDELINES IN THE MRI … Requires SureScan MRI implantable neurostimulator and leads.
Instructions for use!
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