{
  "format": "devicerts.device.v1",
  "cite_as": "PriMatrix® 607-005-440, Tei Biosciences Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/primatrix-r-607-005-440 (data as of 2026-11-14).",
  "source": {
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    "json_url": "https://devicerts.com/devices/primatrix-r-607-005-440.json",
    "markdown_url": "https://devicerts.com/devices/primatrix-r-607-005-440.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA GUDID (AccessGUDID)",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "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/primatrix-r-607-005-440",
    "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": "PriMatrix® 607-005-440",
    "registry_name": "PriMatrix® 607-005-440",
    "url": "https://devicerts.com/devices/primatrix-r-607-005-440",
    "manufacturer": {
      "name": "Tei Biosciences Inc.",
      "url": "https://devicerts.com/manufacturers/tei-biosciences-inc",
      "country": "United States",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "European Union and United States"
    },
    "classification": [
      {
        "class": "Class III",
        "system": "EU MDD"
      },
      {
        "class": "Unclassified",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "Catalogue number",
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          {
            "value": "607-005-440",
            "registries": [
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        "label": "Primary DI / UDI-DI",
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        ]
      },
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          {
            "value": "K153690",
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            ]
          }
        ]
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    ],
    "product_codes": [
      "KGN"
    ],
    "emdn": [
      {
        "code": "M0499",
        "term": "SPECIAL DRESSINGS - OTHER"
      }
    ],
    "gmdn": [
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        "code": "45023",
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      }
    ],
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    "noindex": false
  },
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    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/MDD",
      "number": "B-10381780113447",
      "number_label": "Basic UDI-DI",
      "device_udi_di": "10381780113447",
      "date": "2026-08-18",
      "date_kind": "registered",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
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      "derived_from_gudid": false
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    {
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      "withdrawn": null,
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      "status_note": null,
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    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "GUDID listing",
      "number": "10381780113447",
      "number_label": "UDI-DI",
      "device_udi_di": null,
      "date": "2015-10-21",
      "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": [
    {
      "number": "Z-2078-2023",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2023-05-23",
      "reason": "Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.",
      "applies": "this device",
      "via": "K153690"
    },
    {
      "number": "Z-2077-2023",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2023-05-23",
      "reason": "Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.",
      "applies": "this device",
      "via": "K153690"
    },
    {
      "number": "Z-2079-2023",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2023-05-23",
      "reason": "Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.",
      "applies": "this device",
      "via": "K153690"
    },
    {
      "number": "Z-0383-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-06-15",
      "reason": "During Final Assembly Operation, it was noticed that some of the PriMatrix Instructions for Use (IFUs) from Lot RM1608011 Part 520-002v10 contained extra pages and/or missing pages:\n\" 22 IFUs contained duplicate pages 15 - 26 & 51 - 62 and were also missing pages 27 - 50 \n\" 3 IFUs were missing pages 27 - 50 \n\" 1 IFU was missing pages 1 - 2 & 75 - 76\n\" 1 IFU was missing pages 15 - 62\n\nWhile pages 27  50, 75  76, and 15  62 contain instructions written in a language other than English, pages 1  2 contain information regarding the indications for use, contraindications, device description, warning and precautions, and potential complications of the device.",
      "applies": "this device",
      "via": "K153690"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
      "fields": [
        {
          "label": "Trade name",
          "values": [
            {
              "value": "PriMatrix®",
              "registries": [
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                "FDA GUDID (AccessGUDID)"
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            }
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            }
          ]
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        {
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              "value": "Dermal Repair Scaffold",
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            }
          ]
        },
        {
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        },
        {
          "label": "EU registration type",
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            {
              "value": "Legacy device (under a directive)",
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        },
        {
          "label": "EU market of registration",
          "values": [
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              "value": "Belgium",
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              "registries": [
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        {
          "label": "Prescription use",
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        {
          "label": "Contains latex",
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                "FDA GUDID (AccessGUDID)"
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        {
          "label": "Reprocessed single-use device",
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              "registries": [
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        },
        {
          "label": "Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)",
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            }
          ]
        },
        {
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        {
          "label": "Convenience kit",
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        },
        {
          "label": "Combination product",
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        {
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            }
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            }
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}