{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Esi, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/esi-inc (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/esi-inc",
    "json_url": "https://devicerts.com/manufacturers/esi-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/esi-inc.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA registration and listing",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm"
      }
    ],
    "eudamed_record_synced": null,
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-14",
    "status_as_of": "2026-11-14",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/manufacturers/esi-inc",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "manufacturer": {
    "name": "Esi, Inc.",
    "url": "https://devicerts.com/manufacturers/esi-inc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [
      "Esi"
    ],
    "country": "United States",
    "country_basis": "FDA applicant, unverified",
    "eudamed_status": null,
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "FDA"
    ],
    "identifiers": [
      {
        "label": "FDA FEI",
        "value": "3004181533"
      }
    ],
    "summary": "Esi, Inc. is a medical device manufacturer, with 26 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 14 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 26,
    "devices_note": null,
    "certificates": 0,
    "fda_recalls_matched_by_name": 0,
    "fda_recalls_ongoing": 0,
    "fda_recalls_ongoing_recent": 0,
    "fda_recalls_ongoing_before": null,
    "fda_establishments": 0,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "FDA GUDID",
        "devices": 23
      },
      {
        "registry": "FDA 510(k)",
        "devices": 3
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 24
      },
      {
        "class": "FDA Class I",
        "devices": 2
      }
    ],
    "top_emdn_categories": []
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 26,
    "total": 26,
    "all_devices_url": "https://devicerts.com/manufacturers/esi-inc",
    "items": [
      {
        "name": "Prager Shell® P-103GS",
        "url": "https://devicerts.com/devices/prager-shell-r-p-103gs",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Prager Shell® P106SVGS P106SV Gold Series",
        "url": "https://devicerts.com/devices/prager-shell-r-p106svgs-p106sv-gold-series",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Prager Shell® P-106",
        "url": "https://devicerts.com/devices/prager-shell-r-p-106",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Kera-Flow KF100",
        "url": "https://devicerts.com/devices/kera-flow-kf100",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Prager Shell® P-104SV",
        "url": "https://devicerts.com/devices/prager-shell-r-p-104sv",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Prager Ext Set A1236 011B1236",
        "url": "https://devicerts.com/devices/prager-ext-set-a1236-011b1236",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": true
      },
      {
        "name": "Prager Ext Set B1263 011B1263",
        "url": "https://devicerts.com/devices/prager-ext-set-b1263-011b1263",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": true
      },
      {
        "name": "Prager Shell® P-103",
        "url": "https://devicerts.com/devices/prager-shell-r-p-103",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Prager Shell® P-104",
        "url": "https://devicerts.com/devices/prager-shell-r-p-104",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Prager Shell® P-102-2",
        "url": "https://devicerts.com/devices/prager-shell-r-p-102-2",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Prager Shell® P-110RXP",
        "url": "https://devicerts.com/devices/prager-shell-r-p-110rxp",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Prager Shell® P-102",
        "url": "https://devicerts.com/devices/prager-shell-r-p-102",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Prager Shell® P-105",
        "url": "https://devicerts.com/devices/prager-shell-r-p-105",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Prager Shell® P-100-AS",
        "url": "https://devicerts.com/devices/prager-shell-r-p-100-as",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "ClearScan® CS200",
        "url": "https://devicerts.com/devices/clearscan-r-cs200",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Prager Shell® P-101",
        "url": "https://devicerts.com/devices/prager-shell-r-p-101",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Prager Shell® P-104GS",
        "url": "https://devicerts.com/devices/prager-shell-r-p-104gs",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Prager Shell® P-106GS",
        "url": "https://devicerts.com/devices/prager-shell-r-p-106gs",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Prager Shell® P-107-2",
        "url": "https://devicerts.com/devices/prager-shell-r-p-107-2",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Prager Shell® P-103SV",
        "url": "https://devicerts.com/devices/prager-shell-r-p-103sv",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Prager Shell® P-106SV",
        "url": "https://devicerts.com/devices/prager-shell-r-p-106sv",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Prager Shell® P-100",
        "url": "https://devicerts.com/devices/prager-shell-r-p-100",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Prager Shell® P-101-2",
        "url": "https://devicerts.com/devices/prager-shell-r-p-101-2",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Clearscan",
        "url": "https://devicerts.com/devices/clearscan-itx",
        "model_reference": "K080119",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2008-02-21",
        "open_recall": false
      },
      {
        "name": "Afterloading Gynecological Applicator",
        "url": "https://devicerts.com/devices/afterloading-gynecological-applicator-iwj",
        "model_reference": "K813230",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1981-12-29",
        "open_recall": false
      },
      {
        "name": "Prager Shell",
        "url": "https://devicerts.com/devices/prager-shell-itx",
        "model_reference": "K082893",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2008-12-05",
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": []
}