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Packagehl7.fhir.uv.order-catalog
Resource TypeDeviceDefinition
IdDeviceDefinition-example-devicemodel-presthetics-accessories.json
FHIR VersionR5

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Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: DeviceDefinition example-devicemodel-presthetics-accessories

Language: en-US

Profile: Device Model

Reference to a catalog: Composition Worldwide Device Catalog

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

MarketDistributions

-MarketPeriodSubJurisdiction
*2019-05-05 --> (ongoing)urn:oid:2.16.840.1.113883.3.150

partNumber: P0-3.75,5

manufacturer: A.B. DENTAL DEVICES LTD

DeviceNames

-NameType
*Presthetic AccessoriesRegistered name

modelNumber: P0-3.75,5

classification

type: Dental implant suprastructure kit

Justifications

-TypeCitation
*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.

classification

type: Dental implant suprastructure

classification

type: Dental implants - accessories

packaging

type: Bag, device

count: 10

UdiDeviceIdentifiers

-DeviceIdentifierIssuerJurisdiction
*17290107271407urn:oid:2.51.1.1urn:oid:2.16.840.1.113883.3.150

packaging

type: Bag, device

count: 100

UdiDeviceIdentifiers

-DeviceIdentifierIssuerJurisdiction
*27290107271404urn:oid:2.51.1.1urn:oid:2.16.840.1.113883.3.150

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: Device Packaged as Sterile

value: false

property

type: Requires Sterilization Prior to Use

value: true

contact: Info@ab-dent.com

guideline

relatedArtifact

type: Documentation

label: Device described in GUDID:

Documents

-Url
*https://accessgudid.nlm.nih.gov/devices/07290107271400

Source1

{
  "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": "<!-- snip (see above) -->"
  },
  "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"
        }
      }
    ]
  }
}