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EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II
Device Information The EGENS Pregnancy Test Midstream devices are qualitative immunochromatographic assays designed for early pregnancy detection. They consist of a nitrocellulose test strip housed in plastic, usable in either dip or midstream mode. Both tests detect hCG in urine, indicating pregnancy as early as five days before the expected menstrual period. Midstream I displays…
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Trigon HA Stand-Alone Wedge Fixation System
Device Information: The Trigon HA Stand-Alone Wedge Fixation System consists of PEEK Optima HA Enhanced wedges with tantalum markers. The wedges are designed to provide angular correction of small bones in the foot and include two screw-receiving holes, surface teeth, and an area for grafting material. Available in various shapes (rectangular, kidney, circular, oval, and…
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iFuse Bedrock Granite Implant System
Device Information The iFuse Bedrock Granite Implant System consists of titanium alloy (Ti-6Al-4V ELI) implants of various lengths and diameters. It is designed for both open and minimally invasive surgeries. The implants feature a porous fusion sleeve with a threaded length attached to a solid post, allowing for connection with 5.5 mm or 6.0 mm…
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Epilaser Pro
Device Information The Epilaser Pro uses laser energy at 808 or 980nm wavelengths to target and disable hair follicles. It features a skin tone sensor to ensure appropriate skin compatibility before activation and includes an automatic hair-targeting algorithm for precise treatment. The handheld, noninvasive device has a spot size, peak power, fluence, and pulse duration…
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GEM FLOW NOW (GEM2770-FN)
Device Information The GEM FLOW NOW is composed of an implantable silicone vessel sleeve and a 20 MHz ultrasonic Doppler transducer (probe), which monitors blood flow in peripheral vessels. Indications GEM FLOW NOW monitors blood flow in peripheral vessels during and after reconstructive microvascular procedures, re-implantations, and free flap transfers. Blood flow monitoring can continue…
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Rebuilder Nerve Guidance Conduit
Device Information The Rebuilder Nerve Guidance Conduit is made of bioresorbable poly(lactide-co-caprolactone), a permeable material designed to protect and support peripheral nerve regeneration. It is available in various sizes, with inner diameters ranging from 1.5 mm to 10 mm, and is provided sterile for single use only. The device is packaged in a double-peel package…
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DermRays Revive
Device Information The DermRays Revive uses a diode laser with an output wavelength of 1064nm, which targets tissues like melanin and hemoglobin without damaging the skin. It features a pulse width of 400ms and energy density ranging from 5.0 to 10.0 J/cm², delivered through a 15mm handpiece. The device operates on AC100-240V, 50/60Hz, and is…
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VIVA Combo RF System
Device Information The VIVA Combo RF System is a medical device designed for tissue coagulation and ablation using radiofrequency (RF) energy. It can deliver up to 200W of power with software-controlled limits. It includes a generator, active electrode, grounding pad, and a peristaltic pump for electrode cooling. The system utilizes chilled water in a closed-loop…
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E3D-A Interbody System
Device Information The E3D-A Interbody System’s implants are available with and without HAnano Surface®, a 20-40 nanometer thin hydroxyapatite (HA) surface treatment that presents nano-scale topography on the entirety of the implant surface. Indications The E3D-A Interbody System is used in the thoracolumbar spine to treat conditions like degenerative disc disease (DDD), disc herniation, spondylolisthesis,…
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G-Vitri Vitrification Freeze Media; G-Vitri Vitrification Thawing Media
Device Information Indications This G-Vitri Vitrification Freeze Media and G-Vitri Vitrification Thawing Media are indicated for vitrification (freezing) and thawing of human oocytes (eggs) during fertility treatments. Intended Use This media is intended for medical professionals to use in assisted reproductive technologies. It is designed for the safe vitrification and thawing of human oocytes, primarily…
Medevx
Medical Device Information Database
Medevx 