{
  "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": "2026-10-26",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 9
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Chisel long neg. gouge tip, curved dia. 4 /270mm",
        "Srewdriver tip dia. 5 mm, 120 mm",
        "Long neg. hollow tip dia. 3.2 mm, 270 mm",
        "Foot pedal",
        "SteriTray chisels set",
        "Chisel long pos. gouge tip, curved dia. 4 /270mm",
        "Handpiece Tube",
        "Flexible microstructure chisel -single use- 190mm - 7 mm",
        "OrthoClast 2 base unit",
        "Short negative hollow tip dia. 4 mm, 200 mm",
        "Extraction sleeve",
        "OrthoClast 2 Module 1 - Basic Set",
        "Handpiece OrthoClast",
        "Screwdriver tip hollow dia. 4 mm, 270 mm",
        "Canulated Drill",
        "Chisel microstructure set",
        "Ceramic-inlay tappet",
        "Short negative hollow tip dia. 4 mm, 270 mm",
        "Short negative hollow tip dia. 3,2 mm, 270 mm",
        "Sterilisation tray handpiece",
        "Short neg. hollow curved dia. 4 mm, 270 mm",
        "Flexible microstructure chisel -single use- 160mm - 5 mm thin",
        "Srewdriver tip dia. 3,2 mm, 270 mm",
        "Handpiece holder",
        "Flexible microstructure chisel -single use- 160mm - 7mm",
        "Long positive hollow tip dia. 4 mm, 200 mm"
      ],
      "establishment_type": [
        "Export Device to the United States But Perform No Other Operation on Device"
      ],
      "registration": {
        "registration_number": "9617155",
        "fei_number": "1000345108",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "SUMMIT MEDICAL LTD.",
        "address_line_1": "INDUSTRIAL PARK",
        "address_line_2": "BOURTON ON THE WATER",
        "city": "GLOUCESTERSHIRE",
        "state_code": "",
        "iso_country_code": "GB",
        "zip_code": "",
        "postal_code": "GL54 2HQ",
        "us_agent": {
          "name": "Stephan Toupin",
          "business_name": "Dawa Medical LLC",
          "bus_phone_area_code": "305",
          "bus_phone_num": "5999373",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "stoupin@dawamedical.com",
          "address_line_1": "7320 NW 12th Street",
          "address_line_2": "Suite 103",
          "city": "Miami",
          "state_code": "FL",
          "iso_country_code": "US",
          "zip_code": "33126",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "SUMMIT MEDICAL LTD.",
          "owner_operator_number": "9027741",
          "official_correspondent": {
            "first_name": "Liz",
            "middle_initial": "-",
            "last_name": "Hayward",
            "subaccount_company_name": "",
            "phone_number": "44-14-51821311-x"
          },
          "contact_address": {
            "address_1": "INDUSTRIAL PARK",
            "address_2": "BOURTON ON THE WATER",
            "city": "GLOUCESTERSHIRE",
            "state_code": "GB-NOTA",
            "state_province": "",
            "iso_country_code": "GB",
            "postal_code": "GL54 2HQ"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "HSZ",
          "created_date": "2026-09-18",
          "owner_operator_number": "9027741",
          "exempt": "",
          "openfda": {
            "device_name": "Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.4820",
            "device_class": "1"
          }
        }
      ]
    }
  ]
}