{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-11-02",
    "results": {
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    {
      "has_donation_id_number": "false",
      "mri_safety": "MR Safe",
      "record_status": "Published",
      "is_labeled_as_nrl": "false",
      "is_rx": "true",
      "commercial_distribution_status": "In Commercial Distribution",
      "device_description": "PAPARELLA VENT TUBE W/TAB 1.14MM SILICONE 5 PACK",
      "public_device_record_key": "7c8eae2f-9f23-4f82-be74-1e8b1bf1bdee",
      "has_serial_number": "false",
      "public_version_date": "2021-01-22",
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        "is_sterilization_prior_use": "false"
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      "brand_name": "PAPARELLA VENT TUBE W/TAB",
      "is_combination_product": "false",
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      "product_codes": [
        {
          "code": "ETD",
          "name": "TUBE, TYMPANOSTOMY",
          "openfda": {
            "device_name": "Tube, Tympanostomy",
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            "regulation_number": "874.3880",
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          "supplement_number": "000"
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      ],
      "device_count_in_base_package": "1",
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      "customer_contacts": [
        {
          "phone": "+1(866)472-2363",
          "email": "info@gracemedical.com"
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      "company_name": "Grace Medical, Inc.",
      "public_version_status": "Update",
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      "gmdn_terms": [
        {
          "code": "33794",
          "name": "Tympanostomy tube",
          "definition": "A small, hollow cylinder intended to be implanted, by insertion through the tympanic membrane, for ventilation or drainage of the middle ear. Otherwise known as a myringotomy tube, grommet or an aural vent tube, it is made of materials such as polytetrafluoroethylene (PTFE), polyethylene (PE), silicon elastomer, or porous polyethylene. One type, known as the malleus clip tube, attaches to the malleus. Disposable devices associated with implantation may be included with the device, which may be used to implant bilateral tubes.",
          "implantable": "true",
          "code_status": "Active"
        }
      ],
      "publish_date": "2016-02-18"
    }
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}