{
  "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": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "QXR",
      "openfda": {
        "k_number": [
          "DEN220052"
        ],
        "registration_number": [
          "3017608802",
          "1932738",
          "3011324393"
        ],
        "fei_number": [
          "3017608802",
          "1000143606",
          "3011324393"
        ]
      },
      "review_panel": "RA",
      "medical_specialty": "RA",
      "device_name": "Vaginal Hydrogel Packing System",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Radiology",
      "device_class": "2",
      "definition": "A vaginal hydrogel packing system is a non-powered positioning device composed of a flexible container filled with a hydrogel. The device is intended to reduce the radiation dose delivered to adjacent pelvic organs by temporarily displacing the vaginal wall and  adjacent pelvic tissues during radiation therapy treatment planning and delivery.",
      "regulation_number": "892.5735",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}