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
<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 "example-devicemodel-interbody-fusion-system" (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/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 --> (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>
IG © 2021+ HL7 International - Orders and Observations Work Group. Package hl7.fhir.uv.order-catalog#current based on FHIR 5.0.0. Generated 2023-07-08
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