{
  "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": "2026-10-01",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "has_donation_id_number": "false",
      "mri_safety": "Labeling does not contain MRI Safety Information",
      "record_status": "Published",
      "is_labeled_as_nrl": "false",
      "is_rx": "true",
      "commercial_distribution_status": "In Commercial Distribution",
      "device_description": "Black Leksell Bone Rongeur Light Curved 3mm",
      "public_device_record_key": "5e9cfb44-0355-4faa-af75-c72c0e681ed0",
      "has_serial_number": "true",
      "public_version_date": "2025-04-11",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "true",
        "sterilization_methods": "Moist Heat or Steam Sterilization"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "4",
      "labeler_duns_number": "106135367",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "00840217904827",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "false",
      "is_otc": "false",
      "version_or_model_number": "38-220-03B",
      "has_manufacturing_date": "false",
      "brand_name": "Wiggins Medical",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "HTX",
          "name": "Rongeur",
          "openfda": {
            "device_name": "Rongeur",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.4540",
            "device_class": "1"
          }
        }
      ],
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      "customer_contacts": [
        {
          "phone": "800-497-0851",
          "email": "info@wigginsmedical.com"
        }
      ],
      "catalog_number": "38-220-03B",
      "company_name": "Ebner Medical, LLC",
      "public_version_status": "Update",
      "has_expiration_date": "false",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "33442",
          "name": "Craniofacial rongeur, reusable",
          "definition": "A hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (cartilage, sinew) or bone, through a cutting/biting action, during surgery involving the cranium and/or face (e.g., craniotomy, ethmoidectomy, mastoidectomy, rhinoplasty); it is not dedicated to dental surgery. It is typically made of metal and designed to withstand the forces required to bite over tough/hard tissue. This is a reusable device.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2021-05-22",
      "device_sizes": [
        {
          "type": "Length",
          "value": "9",
          "unit": "Inch"
        },
        {
          "type": "Width",
          "value": "3",
          "unit": "Millimeter"
        }
      ]
    }
  ]
}