{
  "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": {
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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": "false",
      "commercial_distribution_status": "In Commercial Distribution",
      "device_description": "Intended for tissue separation, and other procedures that require a sharp surgical blade to puncture or cut.",
      "public_device_record_key": "919da7a9-3506-4b49-9482-9db3e6cb3ab0",
      "has_serial_number": "true",
      "public_version_date": "2021-03-05",
      "sterilization": {
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        "is_sterilization_prior_use": "false"
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      "public_version_number": "1",
      "labeler_duns_number": "027680821",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "00840113201778",
          "type": "Package",
          "issuing_agency": "GS1",
          "unit_of_use_id": "00840113201761",
          "quantity_per_package": "50",
          "package_status": "In Commercial Distribution"
        },
        {
          "id": "00840113201761",
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          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "true",
      "is_otc": "false",
      "version_or_model_number": "371115",
      "has_manufacturing_date": "false",
      "brand_name": "Bard-Parker ® Carbon Rib-Back Blades",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "GES",
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            "device_name": "Blade, Scalpel",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.4800",
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        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "true",
      "has_lot_or_batch_number": "true",
      "customer_contacts": [
        {
          "phone": "+1(616)698-7100",
          "email": "customerservice@aspensurgical.com"
        }
      ],
      "company_name": "ASPEN SURGICAL PRODUCTS, INC.",
      "public_version_status": "New",
      "has_expiration_date": "true",
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      "gmdn_terms": [
        {
          "code": "37445",
          "name": "Manual scalpel blade, single-use",
          "definition": "An interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractable protective guard made of plastic) may be included. This is a single-use device.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2021-02-25"
    }
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}