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
{
"resourceType" : "DeviceDefinition",
"id" : "example-devicemodel-interbody-fusion-system",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/order-catalog/StructureDefinition/DeviceModel"
]
},
"language" : "en-US",
"text" : {
"status" : "extensions",
"div" : "<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\u00a0(use:\u00a0SECONDARY)</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>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/order-catalog/StructureDefinition/CatalogReference",
"valueReference" : {
"reference" : "Composition/example-device-catalog-header"
}
}
],
"description" : "12mm, 10degree Lateral Interbody Fusion, 22x60mm, PEEK Implant Assembly",
"identifier" : [
{
"use" : "secondary",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
"code" : "UDI",
"display" : "Universal Device Identifier"
}
]
},
"system" : "urn:oid:2.51.1.1",
"value" : "00843210101415"
}
],
"udiDeviceIdentifier" : [
{
"deviceIdentifier" : "B417F12260121",
"issuer" : "urn:oid:2.16.840.1.113883.6.40",
"jurisdiction" : "urn:oid:2.16.840.1.113883.3.150",
"marketDistribution" : [
{
"marketPeriod" : {
"start" : "2017-08-22"
},
"subJurisdiction" : "urn:oid:2.16.840.1.113883.3.150"
}
]
}
],
"manufacturer" : {
"display" : "Altus Spine, LLC"
},
"deviceName" : [
{
"name" : "Imola Interbody Fusion System",
"type" : "registered-name"
}
],
"modelNumber" : "F12260-12",
"classification" : [
{
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/GMDN",
"code" : "60762",
"display" : "Polymeric spinal interbody fusion cage"
}
]
}
},
{
"type" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "257275005",
"display" : "Spinal cage"
}
]
}
},
{
"type" : {
"coding" : [
{
"system" : "urn:oid:1.2.250.1.213.2.68",
"code" : "P090701",
"display" : "Spinal fusion systems"
}
]
}
}
],
"safety" : [
{
"coding" : [
{
"system" : "urn:oid:2.16.840.1.113883.3.26.1.1",
"code" : "C113844",
"display" : "Labeling does not Contain MRI Safety Information"
}
]
}
],
"languageCode" : [
{
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/iso639-1",
"code" : "en-US",
"display" : "American English"
}
]
}
],
"property" : [
{
"type" : {
"text" : "For single use"
},
"valueBoolean" : true
},
{
"type" : {
"text" : "Prescription use"
},
"valueBoolean" : true
},
{
"type" : {
"text" : "Over the counter"
},
"valueBoolean" : false
},
{
"type" : {
"text" : "Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)"
},
"valueBoolean" : false
},
{
"type" : {
"text" : "Length"
},
"valueQuantity" : {
"value" : 60,
"unit" : "millimeter",
"system" : "http://unitsofmeasure.org",
"code" : "mm"
}
},
{
"type" : {
"text" : "Width"
},
"valueQuantity" : {
"value" : 22,
"unit" : "millimeter",
"system" : "http://unitsofmeasure.org",
"code" : "mm"
}
},
{
"type" : {
"text" : "Heigth"
},
"valueQuantity" : {
"value" : 12,
"unit" : "millimeter",
"system" : "http://unitsofmeasure.org",
"code" : "mm"
}
},
{
"type" : {
"text" : "Angle"
},
"valueQuantity" : {
"value" : 10,
"unit" : "degree",
"system" : "http://unitsofmeasure.org",
"code" : "deg"
}
}
],
"contact" : [
{
"system" : "email",
"value" : "Info@altus-spine.com"
}
],
"guideline" : {
"relatedArtifact" : [
{
"type" : "documentation",
"label" : "Device described in GUDID:",
"document" : {
"url" : "https://accessgudid.nlm.nih.gov/devices/B417F12260121"
}
}
]
}
}
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
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change