{
  "format": "devicerts.device.v1",
  "cite_as": "CL8903, Medtronic PS Medical. deviCERTS medical device catalogue. https://devicerts.com/devices/n-a-cl8903 (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/n-a-cl8903",
    "json_url": "https://devicerts.com/devices/n-a-cl8903.json",
    "markdown_url": "https://devicerts.com/devices/n-a-cl8903.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA GUDID (AccessGUDID)",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "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/n-a-cl8903",
    "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": "CL8903",
    "registry_name": "CL8903",
    "url": "https://devicerts.com/devices/n-a-cl8903",
    "manufacturer": {
      "name": "Medtronic PS Medical",
      "url": "https://devicerts.com/manufacturers/medtronic-ps-medical",
      "country": null,
      "country_basis": null,
      "fda_registration_country": "United States"
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "00721902371592",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
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      },
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K050044",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
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    ],
    "product_codes": [
      "HBO"
    ],
    "emdn": [],
    "gmdn": [
      {
        "code": "46953",
        "term": "Scalp wound clip"
      }
    ],
    "description": null,
    "noindex": true
  },
  "authorizations": [
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "GUDID listing",
      "number": "00721902371592",
      "number_label": "UDI-DI",
      "device_udi_di": null,
      "date": "2020-09-12",
      "date_kind": "listed",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Listed",
      "status_note": "GUDID: in commercial distribution",
      "derived_from_gudid": false
    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K050044",
      "number_label": null,
      "device_udi_di": null,
      "date": "2005-02-07",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": true
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
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    {
      "number": "Z-3212-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2018-05-03",
      "reason": "The packaging sterile barrier does not comply with the applicable packaging standard for terminally sterilized medical devices. While the Instructions for Use (IFU) state  Do not use if package has been previously opened or damaged , it is possible that the seal breach may go undetected by the user's naked eye.",
      "applies": "this device",
      "via": "K050044"
    },
    {
      "number": "Z-0622-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-12-20",
      "reason": "Medtronic is initiating a voluntary recall because the products identified above did not adequately demonstrate acceptable packaging performance to current standards.",
      "applies": "this device",
      "via": "K050044"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
      "fields": [
        {
          "label": "Generic name",
          "values": [
            {
              "value": "Scalp wound clip",
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          ]
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        {
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          ]
        }
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    {
      "group": "Identifiers",
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          "label": "Primary DI / UDI-DI",
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            {
              "value": "00721902371592",
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        {
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          ]
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      ]
    },
    {
      "group": "Classification",
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        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
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          ]
        },
        {
          "label": "Regulation number",
          "values": [
            {
              "value": "882.4150",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
        },
        {
          "label": "GUDID distribution status",
          "values": [
            {
              "value": "In Commercial Distribution",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Properties",
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        {
          "label": "Supplied sterile",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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          ]
        },
        {
          "label": "Single use",
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        {
          "label": "Prescription use",
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        {
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          "label": "HCT/P",
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          "label": "Expiration date",
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}