FHIR IG analytics| Package | hl7.fhir.uv.order-catalog |
| Resource Type | DeviceDefinition |
| Id | DeviceDefinition-example-devicemodel-interbody-fusion-system.json |
| FHIR Version | R5 |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
Generated Narrative: DeviceDefinition example-devicemodel-interbody-fusion-system
Language: en-US
Profile: Device Model
Reference to a catalog: Composition Worldwide Device Catalog
description:
12mm, 10degree Lateral Interbody Fusion, 22x60mm, PEEK Implant Assembly
identifier: Universal Device Identifier/00843210101415 (use: secondary, )
udiDeviceIdentifier
deviceIdentifier: B417F12260121
issuer: urn:oid:2.16.840.1.113883.6.40
jurisdiction: urn:oid:2.16.840.1.113883.3.150
MarketDistributions
MarketPeriod SubJurisdiction 2017-08-22 --> (ongoing) urn:oid:2.16.840.1.113883.3.150
manufacturer: Altus Spine, LLC
| Name | Type |
| Imola Interbody Fusion System | Registered name |
modelNumber: F12260-12
classification
type: Polymeric spinal interbody fusion cage
classification
type: Spinal cage
classification
type: Spinal fusion systems
safety: Labeling does not Contain MRI Safety Information
languageCode: English (United States)
property
type: For single use
value: true
property
type: Prescription use
value: true
property
type: Over the counter
value: false
property
type: Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
value: false
property
type: Length
value: 60 millimeter (Details: UCUM codemm = 'mm')
property
type: Width
value: 22 millimeter (Details: UCUM codemm = 'mm')
property
type: Heigth
value: 12 millimeter (Details: UCUM codemm = 'mm')
property
type: Angle
value: 10 degree (Details: UCUM codedeg = 'deg')
contact: Info@altus-spine.com
guideline
relatedArtifact
type: Documentation
label: Device described in GUDID:
Documents
Url https://accessgudid.nlm.nih.gov/devices/B417F12260121
{
"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": "<!-- snip (see above) -->"
},
"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": "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": "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"
}
}
]
}
}