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GentleCath Air for Women
Device Information The GentleCath Air for Women is a sterile, single-use, intermittent urethral catheter. It uses a hydrophilic coating that activates when in contact with water. The catheter is made of Thermoplastic Elastomer (TPE) and is available in three sizes: CH10, CH12, and CH14. It is packaged in a compact, discreet carrying case for ease…
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ADIRA Lateral Plate System
Device Information Device Specifications The ADIRA Lateral Plate System is available in 4-hole, 2-hole, and 1-hole thoracolumbar plates of various sizes to match different patient anatomies and surgical needs. The plates are used with bone screws and can be attached to the anterolateral or lateral portion of the vertebral body of the thoracolumbar spine. Additionally,…
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Facet Aurora Reusable Lancet Base
Device Information Device Specifications: The Facet Aurora Reusable Lancet Base is a reusable, spring-loaded device designed to quickly eject and retract a lancet to obtain a small blood sample for diagnostic purposes. It has been used in the U.S. for over ten years with no significant design changes. It has adjustable depth settings from 0.5…
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BreView
Device Information Device Specifications:BreView is an advanced visualization tool designed for radiologists to optimize MR breast data review and assessment. It provides functionalities like 2D, 3D, and 4D image loading, automated motion correction, image subtraction, and multi-planar reformats. It also includes semi-automated segmentation tools, a graph view for multi-phase datasets, and the ability to export…
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FlexTip Bipolar Electrodes Single-use
Device Information The FlexTip Bipolar Electrodes are single-use, sterile instruments with stainless steel tips and PEBAX tubing insulation. They are compatible with RF generators from Arthrex Inc. (AR-S9800 Synergy) and Sutter Medizintechnik GmbH (K171869 CURIS® RF Generator). Two models are available, both with 2 mm tips, with working lengths of 280 mm and 350 mm.…
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Clariti 1 Day Multifocal (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker
Device Information: This Clariti 1 Day Multifocal (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker is made from somofilcon A, a silicone hydrogel co-polymer, and contains 56% water. The lens helps block harmful UV rays, absorbing 95% of UVB rays and 50% of UVA rays. It has a diameter of 13.0 to…
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AlphaVent Knotless SP PEEK Anchor
Device Information The AlphaVent Knotless SP PEEK Anchors are single-use bone anchors with a screw-in mechanism. They consist of a poly-ether-ether-ketone (PEEK) eyelet and anchor body, pre-assembled on a disposable stainless-steel inserter. This anchor comes in sizes 4.75mm, 5.5mm, and 6.5mm. The anchors can be inserted into the bone using self-punching or a pre-made pilot…
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MR Q; MR Q SUPINE; MR Q SLT
Device Information The MR Q family of devices is an ophthalmic laser system used for various eye surgeries. It includes the MR Q, MR Q SUPINE, and MR Q SLT models. These lasers can perform posterior capsulotomy, iridotomy, and selective laser trabeculoplasty in specific modes. The devices are designed to provide precision during eye surgeries,…
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Arm-type Fully Automatic Digital Blood Pressure Monitor Model BM 92
Device Information: The Digital Blood Pressure Monitor Model BM 92 is non-invasive and uses an oscillometric method to measure blood pressure and pulse rate. It features an arm cuff and an electric pump for inflation, with a rapid deflation valve. The device measures pressures up to 299 mmHg and pulse rates from 30 to 180…
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LifeOutcomes C-Quest Blood Culture Sampling Device
Device Information The LifeOutcomes C-Quest Blood Culture Sampling Device is a blood collection system designed to sequester the first portion of blood samples to reduce contamination in blood cultures. The device includes three main components: the tee body assembly, a universal culture tube holder, and a third-party FDA-cleared 5 ml diversion syringe. Indications This devicee…
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Medical Device Information Database
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