<?xml version="1.0" encoding="UTF-8"?>

<DeviceDefinition xmlns="http://hl7.org/fhir">
  <id value="example-devicemodel-interbody-fusion-system"/>
  <meta>
    <profile value="http://hl7.org/fhir/uv/order-catalog/StructureDefinition/DeviceModel"/>
  </meta>
  <language value="en-US"/>
  <text>
    <status value="extensions"/><div xmlns="http://www.w3.org/1999/xhtml" xml:lang="en-US" lang="en-US"><p class="res-header-id"><b>Generated Narrative: DeviceDefinition example-devicemodel-interbody-fusion-system</b></p><a name="example-devicemodel-interbody-fusion-system"> </a><a name="hcexample-devicemodel-interbody-fusion-system"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Language: en-US</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-DeviceModel.html">Device Model</a></p></div><p><b>Reference to a catalog</b>: <a href="Composition-example-device-catalog-header.html">Composition Worldwide Device Catalog</a></p><p><b>description</b>: </p><div><p>12mm, 10degree Lateral Interbody Fusion, 22x60mm, PEEK Implant Assembly</p>
</div><p><b>identifier</b>: Universal Device Identifier/00843210101415 (use: secondary, )</p><blockquote><p><b>udiDeviceIdentifier</b></p><p><b>deviceIdentifier</b>: B417F12260121</p><p><b>issuer</b>: urn:oid:2.16.840.1.113883.6.40</p><p><b>jurisdiction</b>: urn:oid:2.16.840.1.113883.3.150</p><h3>MarketDistributions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>MarketPeriod</b></td><td><b>SubJurisdiction</b></td></tr><tr><td style="display: none">*</td><td>2017-08-22 --&gt; (ongoing)</td><td>urn:oid:2.16.840.1.113883.3.150</td></tr></table></blockquote><p><b>manufacturer</b>: Altus Spine, LLC</p><h3>DeviceNames</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td>Imola Interbody Fusion System</td><td>Registered name</td></tr></table><p><b>modelNumber</b>: F12260-12</p><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/GMDN 60762}">Polymeric spinal interbody fusion cage</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://snomed.info/sct 257275005}">Spinal cage</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{urn:oid:1.2.250.1.213.2.68 P090701}">Spinal fusion systems</span></p></blockquote><p><b>safety</b>: <span title="Codes:{urn:oid:2.16.840.1.113883.3.26.1.1 C113844}">Labeling does not Contain MRI Safety Information</span></p><p><b>languageCode</b>: <span title="Codes:{urn:ietf:bcp:47 en-US}">English (United States)</span></p><blockquote><p><b>property</b></p><p><b>type</b>: <span title="Codes:">For single use</span></p><p><b>value</b>: true</p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title="Codes:">Prescription use</span></p><p><b>value</b>: true</p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title="Codes:">Over the counter</span></p><p><b>value</b>: false</p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title="Codes:">Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)</span></p><p><b>value</b>: false</p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title="Codes:">Length</span></p><p><b>value</b>: 60 millimeter<span style="background: LightGoldenRodYellow"> (Details: UCUM  codemm = 'mm')</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title="Codes:">Width</span></p><p><b>value</b>: 22 millimeter<span style="background: LightGoldenRodYellow"> (Details: UCUM  codemm = 'mm')</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title="Codes:">Heigth</span></p><p><b>value</b>: 12 millimeter<span style="background: LightGoldenRodYellow"> (Details: UCUM  codemm = 'mm')</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title="Codes:">Angle</span></p><p><b>value</b>: 10 degree<span style="background: LightGoldenRodYellow"> (Details: UCUM  codedeg = 'deg')</span></p></blockquote><p><b>contact</b>: <a href="mailto:Info@altus-spine.com">Info@altus-spine.com</a></p><blockquote><p><b>guideline</b></p><blockquote><p><b>relatedArtifact</b></p><p><b>type</b>: Documentation</p><p><b>label</b>: Device described in GUDID:</p><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://accessgudid.nlm.nih.gov/devices/B417F12260121">https://accessgudid.nlm.nih.gov/devices/B417F12260121</a></td></tr></table></blockquote></blockquote></div>
  </text>
  <extension url="http://hl7.org/fhir/uv/order-catalog/StructureDefinition/CatalogReference">
    <valueReference>
      <reference value="Composition/example-device-catalog-header"/>
    </valueReference>
  </extension>
  <description value="12mm, 10degree Lateral Interbody Fusion, 22x60mm, PEEK Implant Assembly"/>
  <identifier>
    <use value="secondary"/>
    <type>
      <coding>
        <system value="http://terminology.hl7.org/CodeSystem/v2-0203"/>
        <code value="UDI"/>
        <display value="Universal Device Identifier"/>
      </coding>
    </type>
    <system value="urn:oid:2.51.1.1"/>
    <value value="00843210101415"/>
  </identifier>
  <udiDeviceIdentifier>
    <deviceIdentifier value="B417F12260121"/>
    <issuer value="urn:oid:2.16.840.1.113883.6.40"/>
    <jurisdiction value="urn:oid:2.16.840.1.113883.3.150"/>
    <marketDistribution>
      <marketPeriod>
        <start value="2017-08-22"/>
      </marketPeriod>
      <subJurisdiction value="urn:oid:2.16.840.1.113883.3.150"/>
    </marketDistribution>
  </udiDeviceIdentifier>
  <manufacturer>
    <display value="Altus Spine, LLC"/>
  </manufacturer>
  <deviceName>
    <name value="Imola Interbody Fusion System"/>
    <type value="registered-name"/>
  </deviceName>
  <modelNumber value="F12260-12"/>
  <classification>
    <type>
      <coding>
        <system value="http://terminology.hl7.org/CodeSystem/GMDN"/>
        <code value="60762"/>
        <display value="Polymeric spinal interbody fusion cage"/>
      </coding>
    </type>
  </classification>
  <classification>
    <type>
      <coding>
        <system value="http://snomed.info/sct"/>
        <code value="257275005"/>
        <display value="Spinal cage"/>
      </coding>
    </type>
  </classification>
  <classification>
    <type>
      <coding>
        <system value="urn:oid:1.2.250.1.213.2.68"/>
        <code value="P090701"/>
        <display value="Spinal fusion systems"/>
      </coding>
    </type>
  </classification>
  <safety>
    <coding>
      <system value="urn:oid:2.16.840.1.113883.3.26.1.1"/>
      <code value="C113844"/>
      <display value="Labeling does not Contain MRI Safety Information"/>
    </coding>
  </safety>
  <languageCode>
    <coding>
      <system value="urn:ietf:bcp:47"/>
      <code value="en-US"/>
      <display value="English (United States)"/>
    </coding>
  </languageCode>
  <property>
    <type>
      <text value="For single use"/>
    </type>
    <valueBoolean value="true"/>
  </property>
  <property>
    <type>
      <text value="Prescription use"/>
    </type>
    <valueBoolean value="true"/>
  </property>
  <property>
    <type>
      <text value="Over the counter"/>
    </type>
    <valueBoolean value="false"/>
  </property>
  <property>
    <type>
      <text value="Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)"/>
    </type>
    <valueBoolean value="false"/>
  </property>
  <property>
    <type>
      <text value="Length"/>
    </type>
    <valueQuantity>
      <value value="60"/>
      <unit value="millimeter"/>
      <system value="http://unitsofmeasure.org"/>
      <code value="mm"/>
    </valueQuantity>
  </property>
  <property>
    <type>
      <text value="Width"/>
    </type>
    <valueQuantity>
      <value value="22"/>
      <unit value="millimeter"/>
      <system value="http://unitsofmeasure.org"/>
      <code value="mm"/>
    </valueQuantity>
  </property>
  <property>
    <type>
      <text value="Heigth"/>
    </type>
    <valueQuantity>
      <value value="12"/>
      <unit value="millimeter"/>
      <system value="http://unitsofmeasure.org"/>
      <code value="mm"/>
    </valueQuantity>
  </property>
  <property>
    <type>
      <text value="Angle"/>
    </type>
    <valueQuantity>
      <value value="10"/>
      <unit value="degree"/>
      <system value="http://unitsofmeasure.org"/>
      <code value="deg"/>
    </valueQuantity>
  </property>
  <contact>
    <system value="email"/>
    <value value="Info@altus-spine.com"/>
  </contact>
  <guideline>
    <relatedArtifact>
      <type value="documentation"/>
      <label value="Device described in GUDID:"/>
      <document>
        <url value="https://accessgudid.nlm.nih.gov/devices/B417F12260121"/>
      </document>
    </relatedArtifact>
  </guideline>
</DeviceDefinition>