{
  "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,
      "total": 281
    }
  },
  "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": "Not in Commercial Distribution",
      "device_description": "STYLET 609355 STRT EXTD TPR GLBL EIFU",
      "public_device_record_key": "8bacde74-5eae-4d25-8ad0-c17ed33f3559",
      "has_serial_number": "false",
      "storage": [
        {
          "type": "Storage Environment Temperature",
          "high": {
            "unit": "Degrees Fahrenheit",
            "value": "104"
          },
          "low": {
            "unit": "Degrees Fahrenheit"
          }
        },
        {
          "type": "Storage Environment Temperature",
          "high": {
            "unit": "Degrees Celsius",
            "value": "40"
          },
          "low": {
            "unit": "Degrees Celsius"
          }
        }
      ],
      "public_version_date": "2023-03-16",
      "commercial_distribution_end_date": "2022-01-20",
      "sterilization": {
        "is_sterile": "true",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "2",
      "labeler_duns_number": "006261481",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "00763000059194",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "true",
      "is_otc": "false",
      "version_or_model_number": "609355",
      "has_manufacturing_date": "false",
      "brand_name": "NA",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "DRB",
          "name": "STYLET, CATHETER",
          "openfda": {
            "device_name": "Stylet, Catheter",
            "medical_specialty_description": "Cardiovascular",
            "regulation_number": "870.1380",
            "device_class": "2"
          }
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "true",
      "has_lot_or_batch_number": "true",
      "customer_contacts": [
        {
          "phone": "+1(800)633-8766",
          "email": "Corporate.UDI@medtronic.com"
        }
      ],
      "company_name": "MEDTRONIC, INC.",
      "public_version_status": "Update",
      "has_expiration_date": "false",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "46717",
          "name": "Pacing/defibrillation lead stylet",
          "definition": "A sterile wire, intended to be percutaneously inserted into the coronary venous vasculature to aid in the transvenous placement and/or removal of implantable pacemaker/defibrillator leads; it may in addition be intended to extract an indwelling catheter or other foreign object. It is manipulated proximally with a handle, and its working end is typically made of extremely thin stainless steel wire (e.g., 0.4 mm to 0.81 mm in diameter), and may be available in various wire lengths and degrees of rigidity. This is a single-use device.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2018-08-19",
      "device_sizes": [
        {
          "type": "Outer Diameter",
          "value": "0.406",
          "unit": "Millimeter"
        },
        {
          "type": "Length",
          "value": "55.0",
          "unit": "Centimeter"
        },
        {
          "type": "Outer Diameter",
          "value": "0.016",
          "unit": "Inch"
        }
      ]
    }
  ]
}