{
  "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": "KIT, GU LAPAROSCOPY, LAHEY",
      "public_device_record_key": "d48641b6-7f8a-4a78-88cf-d8c8c1c74526",
      "has_serial_number": "false",
      "storage": [
        {
          "type": "Storage Environment Temperature",
          "high": {
            "unit": "Degrees Celsius",
            "value": "30"
          },
          "low": {
            "unit": "Degrees Celsius",
            "value": "15"
          }
        }
      ],
      "public_version_date": "2021-12-10",
      "sterilization": {
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        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "1",
      "labeler_duns_number": "961027315",
      "is_labeled_as_no_nrl": "true",
      "identifiers": [
        {
          "id": "50195594459978",
          "type": "Package",
          "issuing_agency": "GS1",
          "unit_of_use_id": "10195594459970",
          "quantity_per_package": "1",
          "package_status": "In Commercial Distribution",
          "package_type": "CASE"
        },
        {
          "id": "10195594459970",
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          "issuing_agency": "GS1"
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      ],
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      "version_or_model_number": "PUVXGALC5",
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      "brand_name": "CARDINAL HEALTH",
      "is_combination_product": "false",
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        {
          "code": "FDE",
          "name": "laparoscopy kit",
          "openfda": {
            "device_name": "Laparoscopy Kit",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
            "device_class": "2"
          }
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "true",
      "has_lot_or_batch_number": "true",
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      "public_version_status": "New",
      "has_expiration_date": "true",
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      "gmdn_terms": [
        {
          "code": "44096",
          "name": "Laparoscopic surgical procedure kit, non-medicated, single-use",
          "definition": "A collection of various sterile laparoscopic and surgical instruments (e.g., access cannulae, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a single-use device.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2021-12-02"
    }
  ]
}