Order Catalog Implementation Guide
1.0.0-ballot - CI Build International flag

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

Example DeviceDefinition: Device model of interbody fusion system

Page standards status: Informative

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

-MarketPeriodSubJurisdiction
*2017-08-22 --> (ongoing)urn:oid:2.16.840.1.113883.3.150

manufacturer: Altus Spine, LLC

DeviceNames

-NameType
*Imola Interbody Fusion SystemRegistered 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