{
  "format": "devicerts.device.v1",
  "cite_as": "Dialfix 11 01, Dfix. deviCERTS medical device catalogue. https://devicerts.com/devices/dialfix-11-01 (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/dialfix-11-01",
    "json_url": "https://devicerts.com/devices/dialfix-11-01.json",
    "markdown_url": "https://devicerts.com/devices/dialfix-11-01.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA GUDID (AccessGUDID)",
        "url": "https://accessgudid.nlm.nih.gov/"
      }
    ],
    "registry_records_last_synced": "2026-10-23",
    "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/devices/dialfix-11-01",
    "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": "Dialfix 11 01",
    "registry_name": "DIALFIX 11 01",
    "url": "https://devicerts.com/devices/dialfix-11-01",
    "manufacturer": {
      "name": "Dfix",
      "url": "https://devicerts.com/manufacturers/dfix",
      "country": null,
      "country_basis": null,
      "fda_registration_country": "United States"
    },
    "status": {
      "state": "listed",
      "label": "Listed",
      "detail": "FDA GUDID listing, no authorization on record"
    },
    "classification": [
      {
        "class": "Class I",
        "system": "US FDA"
      }
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    "identifiers": [
      {
        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "08800125000020",
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            ]
          }
        ]
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    ],
    "product_codes": [
      "MKY"
    ],
    "emdn": [],
    "gmdn": [
      {
        "code": "33873",
        "term": "Skin-closing tension device"
      }
    ],
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    "noindex": true
  },
  "authorizations": [
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "GUDID listing",
      "number": "08800125000020",
      "number_label": "UDI-DI",
      "device_udi_di": null,
      "date": "2023-01-28",
      "date_kind": "listed",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Listed",
      "status_note": "GUDID: in commercial distribution",
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
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      "group": "Identity",
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        {
          "label": "Trade name",
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              "value": "DIALFIX 11",
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          "label": "Model / reference",
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          "label": "Regulation number",
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        {
          "label": "GUDID distribution status",
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          "label": "Implantable",
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        {
          "label": "Premarket exempt",
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          "label": "Contains latex",
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