{ "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" : "

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

\n

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.

\n

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
" }, "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" } }] } }