{
  "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": "2026-09-07",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 17
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Surgical Lap sponge/Abdominal sponge(with x-ray detectable)",
        "Absorbent Gauze rolls/Gauze slice/Zig-zag gauze(with x-ray detectable)",
        "Non woven ball(with x-ray detectable)",
        "Non woven swab/Non woven pad(with x-ray detectable)",
        "Absorbent Surgical Gauze ball/Peanuts ball(with x-ray detectable)",
        "Absorbent Surgical Gauze pad/Gauze swab/Gauze sponge(with x-ray detectable); Non woven ball(with x-ray detectable)",
        "Surgical operation towel(with x-ray detectable)"
      ],
      "establishment_type": [
        "Manufacture Medical Device",
        "Manufacture Medical Device for Another Party (Contract Manufacturer)"
      ],
      "registration": {
        "registration_number": "8030128",
        "fei_number": "3006118668",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "SION BIOTEXT MEDICAL LTD",
        "address_line_1": "3 Eshel St, Sapirim Industrial Park",
        "address_line_2": "",
        "city": "Sderot Southern",
        "state_code": "",
        "iso_country_code": "IL",
        "zip_code": "",
        "postal_code": "8701002",
        "us_agent": {
          "name": "Alan Schwartz",
          "business_name": "mdi Consultants, Inc.",
          "bus_phone_area_code": "516",
          "bus_phone_num": "4829001",
          "bus_phone_extn": "",
          "fax_area_code": "516",
          "fax_num": "4820186",
          "email_address": "info@mdiconsultants.com",
          "address_line_1": "55 Northern Blvd.",
          "address_line_2": "Ste 200",
          "city": "Great Neck",
          "state_code": "NY",
          "iso_country_code": "US",
          "zip_code": "11021",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "SION BIOTEXT MEDICAL LTD",
          "owner_operator_number": "8030128",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "3 Eshel St, Sapirim Industrial Park",
            "address_2": "",
            "city": "Sderot",
            "state_code": "IL-NOTA",
            "state_province": "",
            "iso_country_code": "IL",
            "postal_code": "8701002"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "GDY",
          "created_date": "2018-06-26",
          "owner_operator_number": "8030128",
          "exempt": "",
          "openfda": {
            "device_name": "Gauze/Sponge, Internal, X-Ray Detectable",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.4450",
            "device_class": "1"
          }
        }
      ]
    }
  ]
}