{
  "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": "2026-07-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "OOA",
      "openfda": {
        "k_number": [
          "DEN090011"
        ],
        "registration_number": [
          "3005550381",
          "3008466086",
          "3045925755"
        ],
        "fei_number": [
          "3005550381",
          "3008466086",
          "3045925755"
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      },
      "review_panel": "OB",
      "medical_specialty": "OB",
      "device_name": "Hemorrhoid Prevention Pressure Wedge",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Obstetrics/Gynecology",
      "device_class": "2",
      "definition": "Provides a counter-pressure to the anus during vaginal delivery.  Intended to prevent the occurrence of and/or stop the progression of hemorrhoids associated with vaginal delivery.",
      "regulation_number": "884.5200",
      "implant_flag": "N",
      "submission_type_id": "4"
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  ]
}