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Medical Device Information Database

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  • ExactechGPS System

    Device Information The ExactechGPS System assists surgeons during arthroplasty by providing real-time anatomical data. This image-guided system computes and displays critical information, such as distances and angles for prosthetic placements. It integrates trackers that communicate with a hardware station, providing live feedback to the surgeon during surgery. Indications The ExactechGPS System is intended to assist…

    September 17, 2024
    Orthopedic Surgery
    Image guided surgery, Stereotaxic Instruments, Surgical navigation system, Total knee arthroplasty
  • ViSiGi 3D Gastric Sizing Tube

    Device Information The ViSiGi 3D Gastric Sizing Tube is designed for single-patient use during gastric and bariatric surgery. It features a closed, rounded tip and is available in three sizes: 32 French, 36 French, and 40 French. An integral suction regulator and vented On/Off slide valve are included. An optional squeeze bulb with a pressure…

    September 17, 2024
    Bariatric Surgery, Gastrointestinal Surgery
    Gastric sizing tube
  • Perifit Pump

    Device Information: The Perifit Pump is a wearable electric breast pump designed for lactating women. It includes an adjustable suction system and a closed design to prevent backflow. The device operates through two modes, stimulation and expression, with eight adjustable vacuum levels. It can be controlled manually or via a smartphone app. Indications: The Perifit…

    September 17, 2024
    Obstetrics
    Breast pump
  • Disposable Hemostatic Clips

    Device Information The Disposable Hemostatic Clips are used for endoscopic clip placement in the gastrointestinal tract. The clip is made of stainless steel with high superelasticity, and it can be opened and closed up to five times before deployment. Available in four widths—9 mm, 11mm, 13mm, and 16mm—this clip offers versatility in addressing various lesion…

    September 17, 2024
    Endoscopy, Gastroenterology
    Endoscopic marking
  • Ziehm Vision FD

    Device Information The Ziehm Vision FD is a mobile fluoroscopic imaging system. It features a C-shaped support structure with a high-voltage generator and a flat-panel image receptor. This device uses four manual axes and one motorized axis for precise imaging. It also includes an optional wireless footswitch for flexible operation and supports peripheral devices like…

    September 16, 2024
    Cardiology, Neurology, Orthopedic Surgery, Radiology, Urology
    FLuroscopic imaging, Mobile imaging system, Surgical Imaging
  • One-Fil

    Device Information One-Fil is a premixed, injectable calcium silicate composition used in root canal treatments. It requires water to set and harden. The device includes a syringe, plunger, disposable tips, and a holder for easy application. Its radiopaque material helps in precise dental imaging. Indications One-Fil is intended for the permanent sealing of root canals.…

    September 16, 2024
    Dental Medicine, Endodontics
    Root Canal Sealer
  • M-Wave

    Device Information The M-Wave is designed as a powered muscle stimulator, specifically for muscle re-education, preventing muscle atrophy due to disuse, improving local blood circulation, and enhancing muscle motion range. Additionally, it aids in relaxing muscle spasms, making it versatile for various rehabilitation purposes. Indications The M-Wave device is intended for: Intended Use This device…

    September 16, 2024
    Physical medicine and rehabilitation
    Neuromodulation, Powered muscle stimulator
  • Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile

    Device Information The Powder-Free Nitrile Examination Glove is ambidextrous and comes in various sizes, from Extra Small to Extra Large. It is non-sterile and designed for single use.  Indications The gloves are disposable and intended to prevent contamination between the patient and examiner. They are specifically tested for use with chemotherapy drugs, Fentanyl Citrate, and…

    September 16, 2024
    General Hospital
    Chemotherapy, Disposable gloves, Examination gloves, Non Sterile gloves
  • Aptima Neisseria gonorrhoeae Assay

    Device Information The Aptima Neisseria gonorrhoeae Assay detects Neisseria gonorrhoeae ribosomal RNA (rRNA). It uses a combination of target capture, transcription-mediated amplification (TMA), and hybridization protection assay (HPA) technologies. The assay operates on the Panther system, which automates the process. It tests male urine specimens and reports results using relative light units (RLU). The system…

    September 14, 2024
    Infectious Disease, Microbiology
    Hybridization Protection Assay (HPA), Neisseria Gonorrhoeae, Nucleic Acid Amplification, rRNA, Sexually Transmitted Diseases, Transcription-Mediated Amplification (TMA)
  • CentriMag Acute Circulatory Support System

    Device Information Device Specifications: The CentriMag System is a temporary mechanical circulatory support system. It includes a blood pump, motor, console, and flow probes. The system controls blood flow in extracorporeal membrane oxygenation (ECMO) circuits. It uses MagLev technology to rotate the pump’s impeller and control blood flow. This helps manage acute circulatory failure in…

    September 14, 2024
    Cardiovascular Surgery
    Acute Cardiopulmonary Failure, Acute Respiratory Failure, Blood pump, Cardiopulmonary bypass, Circulatory support, ECMO, Extracorporeal circuit, Maglev Technology
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