{
  "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": 21
    }
  },
  "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": "false",
      "commercial_distribution_status": "In Commercial Distribution",
      "device_description": "All-in-One Scleral Lens Application and Removal Tool",
      "public_device_record_key": "26ce57d0-0ab0-4c83-8ca4-6299b3ecc757",
      "has_serial_number": "false",
      "public_version_date": "2026-03-30",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "2",
      "labeler_duns_number": "266454744",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "03770020907586",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "false",
      "is_otc": "true",
      "version_or_model_number": "4044 SCLE-1",
      "has_manufacturing_date": "true",
      "brand_name": "ScleralEase",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "KYE",
          "name": "Inserter/Remover Contact Lens",
          "openfda": {
            "device_name": "Inserter/Remover Contact Lens",
            "medical_specialty_description": "Ophthalmic",
            "regulation_number": "886.5420",
            "device_class": "1"
          }
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "true",
      "has_lot_or_batch_number": "true",
      "company_name": "ODC INDUSTRIES",
      "public_version_status": "Update",
      "has_expiration_date": "false",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "42810",
          "name": "Rigid contact lens inserter/remover",
          "definition": "A device designed to insert and remove hard and semi-rigid contact lenses from the eye. It typically consists of a small, hand-held device that has a handle and a concave cup-like distal end; some devices include a vented handle that provides manually-adjustable suction for lens removal. The device is used to avoid hard and semi-rigid lens contamination and to facilitate lens removal and insertion typically by users with low dexterity, long nails, or rough fingers; it is also used by contact lens wearers in dirty environments. This is a reusable device.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2026-02-21"
    }
  ]
}