{
  "format": "devicerts.device.v1",
  "cite_as": "Soltive Tfl-Cslu, Gyrus Acmi, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/soltive-tfl-cslu (data as of 2026-11-15).",
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    "markdown_url": "https://devicerts.com/devices/soltive-tfl-cslu.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA GUDID (AccessGUDID)",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
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        "url": "https://ec.europa.eu/tools/eudamed"
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    "registry_records_last_synced": "2026-10-25",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/soltive-tfl-cslu",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
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    "name": "Soltive Tfl-Cslu",
    "registry_name": "SOLTIVE TFL-CSLU",
    "url": "https://devicerts.com/devices/soltive-tfl-cslu",
    "manufacturer": {
      "name": "Gyrus Acmi, Inc.",
      "url": "https://devicerts.com/manufacturers/gyrus-acmi-inc",
      "country": "United States",
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        "class": "Class IIb",
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      {
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    }
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      "applies": "this device",
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    {
      "number": "Z-1923-2025",
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      "reason": "Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.",
      "applies": "this device",
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    {
      "number": "Z-1921-2025",
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      "reason": "Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.",
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    {
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