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Regulatory Information Equipment & Supplies

10 equipment items found

Polyganics NEUROLAC - Adapting Versatile Polymers

Polyganics NEUROLAC - Adapting Versatile Polymers

Manufactured by:Regenity   based inParamus, NEW JERSEY (USA)
Synthetic nerve guides are indicated for reconstruction of peripheral nerve discontinuities up to 20 ...
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AcuPebble - Model RE100 - Continuous Monitoring of Breathing and Cardiac Biosignals for Research

AcuPebble - Model RE100 - Continuous Monitoring of Breathing and Cardiac Biosignals for Research

Manufactured by:Acurable Limited   based inLondon, UNITED KINGDOM
AcuPebble RE100 is a wearable device that fundamentally improves the measurement of respiratory biosignals. It provides more accurate data and enables the continuous monitoring of patients at home in clinical trials and post-market ...
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Polyganics LIQOSEAL - Adapting Versatile Polymers

Polyganics LIQOSEAL - Adapting Versatile Polymers

Manufactured by:Regenity   based inParamus, NEW JERSEY (USA)
The first product in our Neurosurgery portfolio is LIQOSEAL. LIQOSEAL is indicated for use as an adjunct to standard methods of cranial dural repair to provide a watertight closure of the dura mater and reduce cerebrospinal fluid (CSF) ...
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AcuPebble - Model SA100 - FDA Cleared Wearable Medical Device for Home Sleep Apnea Testing

AcuPebble - Model SA100 - FDA Cleared Wearable Medical Device for Home Sleep Apnea Testing

Manufactured by:Acurable Limited   based inLondon, UNITED KINGDOM
Clinically validated: AcuPebble SA100 automated sleep apnea test was validated in a powered clinical trial at the NHS Royal Free London hospital. Validated sleep study result equivalent to ambulatory gold-standard (multi-channel polygraphy followed by manual specialist interpretation). Validated result based on AHI and ODI for both 3% and 4% desaturation criteria with high accuracy (94% PPV, 98% ...
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Polyganics ACTISEAL - General Surgery Product

Polyganics ACTISEAL - General Surgery Product

Manufactured by:Regenity   based inParamus, NEW JERSEY (USA)
The first product in our General Surgery portfolio is ACTISEAL. ACTISEAL is indicated for use to reduce post-operative leakage of fluids from the site of surgery into the abdominal cavity after HPB surgery, and as an adjunctive hemostatic device to control minimal to moderate ...
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SynCardia - Model 50cc TAH - Temporary Total Artificial Heart

SynCardia - Model 50cc TAH - Temporary Total Artificial Heart

Manufactured by:SynCardia Systems, LLC,   based in, ARIZONA (USA)
The SynCardia 50cc temporary Total Artificial Heart (TAH) is a smaller version of the SynCardia 70cc TAH, which has been approved as a bridge to transplant for more than a decade. The 50cc TAH is designed for use as a bridge to transplant in patients of smaller stature, allowing more women and adolescents to access this novel ...
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SynCardia - Model 70cc  TAH - Temporary Total Artificial Heart

SynCardia - Model 70cc TAH - Temporary Total Artificial Heart

Manufactured by:SynCardia Systems, LLC,   based in, ARIZONA (USA)
The SynCardia 70cc temporary Total Artificial Heart (TAH) is the world’s first and only commercially approved total heart replacement. With more than 1,700 implants worldwide, the 70cc TAH accounts for more than 600 patient-years of ...
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AmnioExcel - Amniotic Allograft Membrane

AmnioExcel - Amniotic Allograft Membrane

Manufactured by:Integra LifeSciences   based inPrinceton, NEW JERSEY (USA)
AmnioExcel® Amniotic Allograft Membrane is a human placental-based tissue product processed using a proprietary method. The membrane acts as protective covering when placed over the wound, providing the key components found in human amnion including an intact extracellular matrix (ECM), growth factors and cytokines. AmnioExcel easily molds and conforms to the wound, and helps provide an ...
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GS-International - Model CAS-94-24-6 - Tetracaine

GS-International - Model CAS-94-24-6 - Tetracaine

Manufactured by:GS International Trade Co.,Ltd   based in, CHINA
CAS No.: 94-24-6 (base) / 136-47-0 (hydrochloride). Molecular Formula: C15H24N2O2. Molecular Weight: 264.36 g/mol (base) / 300.82 g/mol (HCl). Appearance: White to off-white crystalline powder (HCl form). Melting Point: 149°C (HCl form). Boiling Point: 389.4°C (HCl form, at 760 mmHg). Density: 1.044 g/cm³ . Refractive Index: 1.520 ...
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Genetic - Molecular Ova and Parasite Screening System

Genetic - Molecular Ova and Parasite Screening System

Manufactured by:Genetic Signatures Ltd.   based inNewtown, AUSTRALIA
In the United States (US), gastrointestinal (GI) protozoan parasites are a significant healthcare burden, with more than 350 million cases of acute GI infections annually. Globally, protozoan infections are the leading cause of mortality of children under five years old.1,2 Hence, the importance of rapid and accurate diagnosis and treatment is essential for decreasing the significant burden of GI ...
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