Order Catalog Implementation Guide, published by HL7 International / Orders and Observations. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. 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
Page standards status: Informative |
{
"resourceType" : "DeviceDefinition",
"id" : "example-devicemodel-presthetics-accessories",
"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 class=\"res-header-id\"><b>Generated Narrative: DeviceDefinition example-devicemodel-presthetics-accessories</b></p><a name=\"example-devicemodel-presthetics-accessories\"> </a><a name=\"hcexample-devicemodel-presthetics-accessories\"> </a><a name=\"example-devicemodel-presthetics-accessories-en-US\"> </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>Titanium Healing Cap, 3.75 mm Diameter, 5 mm lengh</p>\n</div><blockquote><p><b>udiDeviceIdentifier</b></p><p><b>deviceIdentifier</b>: 07290107271400</p><p><b>issuer</b>: urn:oid:2.51.1.1</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>2019-05-05 --> (ongoing)</td><td>urn:oid:2.16.840.1.113883.3.150</td></tr></table></blockquote><p><b>partNumber</b>: P0-3.75,5</p><p><b>manufacturer</b>: A.B. DENTAL DEVICES LTD</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>Presthetic Accessories</td><td>Registered name</td></tr></table><p><b>modelNumber</b>: P0-3.75,5</p><blockquote><p><b>classification</b></p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/GMDN 44881}\">Dental implant suprastructure kit</span></p><h3>Justifications</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Citation</b></td></tr><tr><td style=\"display: none\">*</td><td>Citation</td><td><div><p>A collection of prefabricated dental devices and components used to create a suprastructure on a dental implant to mimic preparations of natural teeth. It is used during dental implant restorative and laboratory procedures and will typically consist of a direct dental abutment (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), a carrier, an impression pick-up, a replica, a healing cap and a burnout cylinder. This is a single-use device.</p>\n</div></td></tr></table></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title=\"Codes:{http://snomed.info/sct 1141761008}\">Dental implant suprastructure</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 P01020180}\">Dental implants - accessories</span></p></blockquote><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title=\"Codes:{http://snomed.info/sct 37284003}\">Bag, device</span></p><p><b>count</b>: 10</p><h3>UdiDeviceIdentifiers</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>DeviceIdentifier</b></td><td><b>Issuer</b></td><td><b>Jurisdiction</b></td></tr><tr><td style=\"display: none\">*</td><td>17290107271407</td><td>urn:oid:2.51.1.1</td><td>urn:oid:2.16.840.1.113883.3.150</td></tr></table><blockquote><p><b>packaging</b></p><p><b>type</b>: <span title=\"Codes:{http://snomed.info/sct 37284003}\">Bag, device</span></p><p><b>count</b>: 100</p><h3>UdiDeviceIdentifiers</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>DeviceIdentifier</b></td><td><b>Issuer</b></td><td><b>Jurisdiction</b></td></tr><tr><td style=\"display: none\">*</td><td>27290107271404</td><td>urn:oid:2.51.1.1</td><td>urn:oid:2.16.840.1.113883.3.150</td></tr></table></blockquote></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:\">Device Packaged as Sterile</span></p><p><b>value</b>: false</p></blockquote><blockquote><p><b>property</b></p><p><b>type</b>: <span title=\"Codes:\">Requires Sterilization Prior to Use</span></p><p><b>value</b>: true</p></blockquote><p><b>contact</b>: <a href=\"mailto:Info@ab-dent.com\">Info@ab-dent.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/07290107271400\">https://accessgudid.nlm.nih.gov/devices/07290107271400</a></td></tr></table></blockquote></blockquote></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/order-catalog/StructureDefinition/CatalogReference",
"valueReference" : {
🔗 "reference" : "Composition/example-device-catalog-header"
}
}
],
"description" : "Titanium Healing Cap, 3.75 mm Diameter, 5 mm lengh",
"udiDeviceIdentifier" : [
{
"deviceIdentifier" : "07290107271400",
"issuer" : "urn:oid:2.51.1.1",
"jurisdiction" : "urn:oid:2.16.840.1.113883.3.150",
"marketDistribution" : [
{
"marketPeriod" : {
"start" : "2019-05-05"
},
"subJurisdiction" : "urn:oid:2.16.840.1.113883.3.150"
}
]
}
],
"partNumber" : "P0-3.75,5",
"manufacturer" : {
"display" : "A.B. DENTAL DEVICES LTD"
},
"deviceName" : [
{
"name" : "Presthetic Accessories",
"type" : "registered-name"
}
],
"modelNumber" : "P0-3.75,5",
"classification" : [
{
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/GMDN",
"code" : "44881",
"display" : "Dental implant suprastructure kit"
}
]
},
"justification" : [
{
"type" : "citation",
"citation" : "A collection of prefabricated dental devices and components used to create a suprastructure on a dental implant to mimic preparations of natural teeth. It is used during dental implant restorative and laboratory procedures and will typically consist of a direct dental abutment (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), a carrier, an impression pick-up, a replica, a healing cap and a burnout cylinder. This is a single-use device."
}
]
},
{
"type" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "1141761008",
"display" : "Dental implant suprastructure"
}
]
}
},
{
"type" : {
"coding" : [
{
"system" : "urn:oid:1.2.250.1.213.2.68",
"code" : "P01020180",
"display" : "Dental implants - accessories"
}
]
}
}
],
"packaging" : [
{
"type" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "37284003",
"display" : "Bag, device"
}
]
},
"count" : 10,
"udiDeviceIdentifier" : [
{
"deviceIdentifier" : "17290107271407",
"issuer" : "urn:oid:2.51.1.1",
"jurisdiction" : "urn:oid:2.16.840.1.113883.3.150"
}
],
"packaging" : [
{
"type" : {
"coding" : [
{
"system" : "http://snomed.info/sct",
"code" : "37284003",
"display" : "Bag, device"
}
]
},
"count" : 100,
"udiDeviceIdentifier" : [
{
"deviceIdentifier" : "27290107271404",
"issuer" : "urn:oid:2.51.1.1",
"jurisdiction" : "urn:oid:2.16.840.1.113883.3.150"
}
]
}
]
}
],
"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" : "urn:ietf:bcp:47",
"code" : "en-US",
"display" : "English (United States)"
}
]
}
],
"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" : "Device Packaged as Sterile"
},
"valueBoolean" : false
},
{
"type" : {
"text" : "Requires Sterilization Prior to Use"
},
"valueBoolean" : true
}
],
"contact" : [
{
"system" : "email",
"value" : "Info@ab-dent.com"
}
],
"guideline" : {
"relatedArtifact" : [
{
"type" : "documentation",
"label" : "Device described in GUDID:",
"document" : {
"url" : "https://accessgudid.nlm.nih.gov/devices/07290107271400"
}
}
]
}
}