{
  "format": "devicerts.device.v1",
  "cite_as": "STERIS 5085 SRT Surgical Table, Steris Corporation. deviCERTS medical device catalogue. https://devicerts.com/devices/steris-413724629 (data as of 2026-11-15).",
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    "publisher": "deviCERTS (devicerts.com)",
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        "registry": "FDA GUDID (AccessGUDID)",
        "url": "https://accessgudid.nlm.nih.gov/"
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        "url": "https://ec.europa.eu/tools/eudamed"
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      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "registry_records_last_synced": "2026-10-24",
    "status_as_of": "2026-11-15",
    "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/devices/steris-413724629",
    "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."
  },
  "device": {
    "name": "STERIS 5085 SRT Surgical Table",
    "registry_name": "STERIS 5085 SRT Surgical Table",
    "url": "https://devicerts.com/devices/steris-413724629",
    "manufacturer": {
      "name": "Steris Corporation",
      "url": "https://devicerts.com/manufacturers/steris-corporation",
      "country": "United States",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "European Union and United States"
    },
    "classification": [
      {
        "class": "Class I",
        "system": "EU MDR / US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "Catalogue number",
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          {
            "value": "413724629",
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            ]
          }
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      {
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        "values": [
          {
            "value": "00724995155551",
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              "FDA GUDID (AccessGUDID)"
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          }
        ]
      },
      {
        "label": "Basic UDI-DI",
        "values": [
          {
            "value": "0724995MG5085SRTSGTBL6L",
            "registries": [
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            ]
          }
        ]
      },
      {
        "label": "510(k) Number",
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          {
            "value": "K090136",
            "registries": [
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          }
        ]
      }
    ],
    "product_codes": [
      "FQO"
    ],
    "emdn": [
      {
        "code": "Z12011202",
        "term": "OPERATING TABLES"
      }
    ],
    "gmdn": [
      {
        "code": "33152",
        "term": "Universal operating table, electromechanical"
      }
    ],
    "description": null,
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/MDR",
      "number": "0724995MG5085SRTSGTBL6L",
      "number_label": "Basic UDI-DI",
      "device_udi_di": "00724995155551",
      "date": "2026-09-16",
      "date_kind": "registered",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
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    {
      "registry": "GUDID",
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      "type": "GUDID listing",
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      "device_udi_di": null,
      "date": "2021-03-31",
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      "decision_code": null,
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      "withdrawn": null,
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      "status_note": "GUDID: in commercial distribution",
      "derived_from_gudid": false
    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K090136",
      "number_label": null,
      "device_udi_di": null,
      "date": "2009-03-20",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": true
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [
    {
      "number": "Z-0196-2015",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2014-10-10",
      "reason": "The 5085 and 5085SRT stainless steel column shrouds may become damaged as a result of misalignment during extreme table articulation, excessive side force on the table column, or pressure on the base of the table.   Severe damage to the shrouds may prevent the user from raising or lowering the surgical table.",
      "applies": "shared submission",
      "via": "K090136"
    },
    {
      "number": "Z-2426-2012",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2012-04-06",
      "reason": "STERIS has learned from Customer feedback and field service experience that damage from external impact to the table hydraulic column can cause the stainless steel shroud sections covering the table hydraulic column to become misaligned; if the damage is severe, the up/down movement of the table may be impeded.  In addition, the table hand control may indicate that the table floor locks are unlock",
      "applies": "shared submission",
      "via": "K090136"
    },
    {
      "number": "Z-0279-2012",
      "classification": "",
      "status": "terminated",
      "initiated": "2011-10-17",
      "reason": "Some hydraulic column cylinders installed in certain 5085 and 5085SRT Surgical Tables were assembled by their supplier with incorrect snap rings and an anomaly was present in the tilt cylinder. This error may affect the user's ability to move the table top out of the full right tilt position.",
      "applies": "this device",
      "via": "K090136"
    },
    {
      "number": "Z-1941-2010",
      "classification": "",
      "status": "terminated",
      "initiated": "2010-05-14",
      "reason": "STERIS has learned that a limited quantity of manifold assemblies were manufactured by our supplier with incorrect washers and springs in the valves of the manifold.  This supplier error has the potential to cause: a) an inability to articulate/move a table section when commanded by the operator; b) two different articulations occurring when a single articulation is commanded, or c) that the table",
      "applies": "this device",
      "via": "K090136"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
      "fields": [
        {
          "label": "Trade name",
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            {
              "value": "STERIS",
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        },
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          ]
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            {
              "value": "878.4960",
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            }
          ]
        },
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          "label": "EU registration type",
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            {
              "value": "Standard device",
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            }
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}
