{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "Y",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "OCE",
      "openfda": {
        "registration_number": [
          "1226230"
        ],
        "fei_number": [
          "3002836339"
        ]
      },
      "review_panel": "SU",
      "medical_specialty": "",
      "device_name": "Cultured Epithelial Autograft",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Unknown",
      "device_class": "f",
      "definition": "Interactive wound and burn dressing containing a live xenogeneic component.  Indicated for use in patients who have deep dermal or full thickness burns comprising a total body surface area of greater than or equal to 30%.  It may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.",
      "regulation_number": "",
      "implant_flag": "Y",
      "submission_type_id": "6"
    }
  ]
}