{
  "format": "devicerts.device.v1",
  "cite_as": "SRP BrainStorm, Surgical Theater LLC. deviCERTS medical device catalogue. https://devicerts.com/devices/srp-brainstorm-brainstorm (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/srp-brainstorm-brainstorm",
    "json_url": "https://devicerts.com/devices/srp-brainstorm-brainstorm.json",
    "markdown_url": "https://devicerts.com/devices/srp-brainstorm-brainstorm.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": "2026-10-21",
    "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/srp-brainstorm-brainstorm",
    "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": "SRP BrainStorm",
    "registry_name": "SRP BrainStorm",
    "url": "https://devicerts.com/devices/srp-brainstorm-brainstorm",
    "manufacturer": {
      "name": "Surgical Theater LLC",
      "url": "https://devicerts.com/manufacturers/surgical-theater-llc",
      "country": "United States",
      "country_basis": "FDA 510(k) applicant",
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "00860003884119",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      },
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K201465",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "LLZ"
    ],
    "emdn": [],
    "gmdn": [
      {
        "code": "61486",
        "term": "Surgical simulation system"
      }
    ],
    "description": null,
    "noindex": true
  },
  "authorizations": [
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "GUDID listing",
      "number": "00860003884119",
      "number_label": "UDI-DI",
      "device_udi_di": null,
      "date": "2020-12-08",
      "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": "K201465",
      "number_label": null,
      "device_udi_di": null,
      "date": "2020-07-17",
      "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-0325-2026",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2025-09-16",
      "reason": "A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.",
      "applies": "this device",
      "via": "K201465"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
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        {
          "label": "Generic name",
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            {
              "value": "Surgical simulation system",
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          ]
        },
        {
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            {
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              "registries": [
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            }
          ]
        }
      ]
    },
    {
      "group": "Identifiers",
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          "label": "Primary DI / UDI-DI",
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            {
              "value": "00860003884119",
              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K201465",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "LLZ",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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          ]
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        {
          "label": "GMDN term",
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    },
    {
      "group": "Classification",
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        {
          "label": "Device class",
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            {
              "value": "Class II",
              "registries": [
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          ]
        },
        {
          "label": "Regulation number",
          "values": [
            {
              "value": "892.2050",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
        },
        {
          "label": "GUDID distribution status",
          "values": [
            {
              "value": "In Commercial Distribution",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
        }
      ]
    },
    {
      "group": "Properties",
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        {
          "label": "Prescription use",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
        },
        {
          "label": "Serial number",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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        },
        {
          "label": "Supplied sterile",
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            {
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        {
          "label": "Sterilise before use",
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        {
          "label": "Implantable",
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        {
          "label": "Contains latex",
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        {
          "label": "Convenience kit",
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          "label": "Combination product",
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        {
          "label": "Lot / batch number",
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          "label": "Expiration date",
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}