Order Catalog Implementation Guide
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Order Catalog Implementation Guide, published by HL7 International - Orders and Observations Work Group. This is not an authorized publication; it is the continuous build for version current). This version is based on the current content of https://github.com/HL7/fhir-order-catalog/ and changes regularly. See the Directory of published versions

: Device model of interbody fusion system - XML Representation

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<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><b>Generated Narrative: DeviceDefinition</b><a name="example-devicemodel-interbody-fusion-system"> </a></p><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">Resource DeviceDefinition &quot;example-devicemodel-interbody-fusion-system&quot;  (Language &quot;en-US&quot;) </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/example-device-catalog-header</a></p><p><b>description</b>: 12mm, 10degree Lateral Interbody Fusion, 22x60mm, PEEK Implant Assembly</p><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>: <code>urn:oid:2.16.840.1.113883.6.40</code></p><p><b>jurisdiction</b>: <code>urn:oid:2.16.840.1.113883.3.150</code></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><code>urn:oid:2.16.840.1.113883.3.150</code></td></tr></table></blockquote><p><b>manufacturer</b>: <span>: Altus Spine, LLC</span></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>: Polymeric spinal interbody fusion cage <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-GMDN.html">Global Medical Device Nomenclature</a>#60762)</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: Spinal cage <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="https://browser.ihtsdotools.org/">SNOMED CT</a>#257275005)</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: Spinal fusion systems <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (unknown#P090701)</span></p></blockquote><p><b>safety</b>: Labeling does not Contain MRI Safety Information <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (unknown#C113844)</span></p><p><b>languageCode</b>: American English <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-iso639-1.html">ISO 639-1: Codes for the representation of names of languages -- Part 1: Alpha-2 code</a>#en-US)</span></p><blockquote><p><b>property</b></p><p><b>type</b>: For single use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>value</b>: true</p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Prescription use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>value</b>: true</p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Over the counter <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>value</b>: false</p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>value</b>: false</p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Length <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>value</b>: 60 millimeter<span style="background: LightGoldenRodYellow"> (Details: UCUM code mm = 'mm')</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Width <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>value</b>: 22 millimeter<span style="background: LightGoldenRodYellow"> (Details: UCUM code mm = 'mm')</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Heigth <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>value</b>: 12 millimeter<span style="background: LightGoldenRodYellow"> (Details: UCUM code mm = 'mm')</span></p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: Angle <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>value</b>: 10 degree<span style="background: LightGoldenRodYellow"> (Details: UCUM code deg = '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><blockquote><p><b>document</b></p></blockquote></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="http://terminology.hl7.org/CodeSystem/iso639-1"/>
      <code value="en-US"/>
      <display value="American English"/>
    </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>