№ files_lp_4_process_3_102475
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Character count: 12806
File size: 43 KB
Guidance document detailing procedures and responsibilities for identifying and documenting the UDI Labeler for medical and dental devices distributed commercially in the United States.
Year:
2026
Region / Country:
United States
Subject:
Medical and dental device labeling and regulatory compliance
Document Type:
Standard Operating Procedure (SOP)
Organization:
Carestream Health
Author:
Regulatory Affairs Department
Target Audience:
Project teams, business managers, regulatory and purchasing personnel
Effective Period:
Indefinite until updated
Approval Date:
2026-03-12
Revision Date:
Not specified
Scope:
Devices, items, and parts requiring Unique Device Identifier (UDI) under FDA regulations
Procedures Included:
Labeler determination, documentation requirements, contractual responsibilities
Device Types:
Electronic and non-electronic medical devices
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2018
Region / City:
International
Topic:
Medical Device Identification
Document Type:
Application Guide
Organization / Institution:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF UDI WG
Target Audience:
Medical device regulatory authorities, manufacturers, healthcare stakeholders
Period of validity:
Not specified
Approval Date:
12 July 2018
Date of Changes:
Not specified
Context:
This document provides a detailed guide on implementing a harmonized Unique Device Identification (UDI) system for medical devices to aid regulatory authorities, manufacturers, and stakeholders in the healthcare supply chain.
Year:
2018
Region / city:
International
Topic:
Medical device regulation
Document type:
Proposed document
Organization / institution:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF UDI WG
Target audience:
Medical device regulators
Period of validity:
Ongoing
Approval date:
12 July 2018
Date of changes:
None
Year:
2013
Region / city:
Global
Topic:
Medical Devices, UDI System
Document Type:
Guidance
Organization / Institution:
IMDRF
Author:
IMDRF UDI Working Group
Target Audience:
Regulatory authorities, healthcare professionals, manufacturers
Period of validity:
Not specified
Approval date:
9 December 2013
Date of revisions:
Not specified
Year:
2022
Region / City:
London, United Kingdom
Topic:
Dental Implantology, Governance, Charity Operations
Document Type:
AGM Notice and Reports
Organization / Institution:
Association of Dental Implantology (ADI)
Author:
Richard Cantillon (Acting Executive Director)
Target Audience:
ADI members, dental professionals, charity stakeholders
Period of Validity:
2022
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2012
Region / City:
Falls Church, VA
Topic:
TRICARE Dental Program, Data Exchange
Document Type:
Interface Control Document (ICD)
Organization / Institution:
DHSS Program Executive Office
Author:
Not specified
Target Audience:
DHSS Program Executive Office, TMA Contract Operations Office
Period of Validity:
Ongoing
Approval Date:
June 7, 2012
Date of Changes:
May 25, 2012
Note:
Year
Note:
Year
Institution:
University of Glasgow
Target Audience:
BDS Students
Year:
2014
Region / City:
United States
Topic:
HIPAA compliance, Dental practice, Patient information security
Document Type:
Guidance document
Organization / Institution:
American Dental Association (ADA)
Author:
American Dental Association
Target Audience:
Dental practices, healthcare providers
Period of validity:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Age group:
Adults aged 16 and over
Geographic area:
Bristol, United Kingdom
Healthcare sector:
Dentistry
Dental specialty:
Special Care Dentistry
Document type:
Patient referral form
Issuing institution:
Bristol Dental Hospital
Receiving department:
Patient Access Team
Referral urgency options:
Urgent; Routine
Referral purpose:
Specialist opinion; Specialist opinion and treatment
Clinical information required:
Dental needs; past dental history; difficulties encountered
Medical information required:
Medical history; medications; allergies; smoking and drinking history; involvement of other medical specialties
Accessibility information:
Communication ability; interpreter needs; mobility; transport requirements
Consent requirement:
Patient or carer consent to referral
Acceptance criteria:
Adults with complex medical, physical, neurological, behavioural, psychiatric, bariatric, or allergy-related needs unsuitable for primary care
Regulatory references:
NHS; GDC/GMC
Source type:
Administrative healthcare form used within secondary care referral pathways
Year:
2019
Region / City:
United States
Topic:
Medical Gas Systems
Document Type:
Specification
Organization:
Department of Veterans Affairs (VA)
Author:
Not specified
Target Audience:
Contractors, Installers, Designers
Period of Validity:
Not specified
Approval Date:
Not specified
Revision Date:
Not specified
Year:
2017
Region / city:
Wisconsin, Madison
Subject:
Radiation safety policy for dental facilities
Document type:
Regulatory guide
Institution / organization:
Department of Health Services, Division of Public Health, Radiation Protection Section
Author:
Wisconsin Department of Health Services
Target audience:
Dental facilities and operators
Period of validity:
Ongoing
Approval date:
April 2017
Date of changes:
N/A
Year:
2016
Month:
September
Geographical scope:
Wales
Document type:
Professional guidance
Issuing body:
National Safeguarding Team (NHS Wales)
Contributing organizations:
Public Health Wales; Welsh Government
Authors:
Nigel Farr; Linda Davies; Annette Blackstock; Lisa Howells; David Hannington; Elizabeth Hunt; Kirstie Moons
Sector:
Dental care and public health
Legal context:
Social Services and Well-being (Wales) Act 2014
Related standards:
Welsh Government Health and Care Standards; General Dental Council Standards for the Dental Team
Target audience:
Dental teams, including dentists and dental care professionals
Replaces:
Guidance published in 2011
Subject coverage:
Safeguarding children, young people, and adults at risk; abuse indicators; reporting duties; confidentiality; record keeping
Period of application:
From April 2016
Year:
2024
Region / City:
Not specified
Topic:
Dental treatment
Document Type:
Consent form
Organization / Institution:
MedPro Group Inc.
Author:
Not specified
Target Audience:
Patients receiving dental implant treatments
Effective Period:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
FedBizOpps Sources Sought Notice for Dental Microscopes (BNOE), Veterans Health Administration, 2019
Year:
2019
Country:
United States
Agency:
Department of Veterans Affairs
Sub-agency:
Veterans Health Administration
Program:
Non-Expendable Equipment National Program
Notice type:
Sources Sought Notice
Procurement stage:
Market research
Regulatory framework:
FAR 15.201 and FAR 10.001
Subject area:
Dental microscopes
Equipment category:
Non-expendable medical equipment
Brand name or equal:
Yes
NAICS code:
339114
Solicitation number:
36U10119Q0078
Response due date:
08-13-2019
Response time:
5:00 PM EDT
Place of performance:
Multiple VHA facilities nationwide
Contracting office:
Procurement & Logistics Office (10NA2)
Primary point of contact:
Annette Holland, Requirements Planner
Secondary point of contact:
Jeff Young
Questionnaire portal:
http://data.mcix.com/NXDM
Supporting office:
Office of Small and Disadvantaged Business Utilization
Year:
2021
Region / City:
ACT
Topic:
Radiation Protection
Document Type:
Radiation Management Plan
Organ / Institution:
ACT Health
Author:
Insert Name
Target Audience:
Dental Practitioners, Radiation Safety Officers
Period of Validity:
12 months from submission
Approval Date:
Insert Date
Date of Changes:
N/A
Year:
2015
Region / city:
N/A
Topic:
Dental Readiness Classification
Document Type:
Technical specification
Organization / institution:
N/A
Author:
C. Kangas, W. Funk, A. Hong, D. McDonald
Target Audience:
Military healthcare personnel, data processors
Effective Period:
Monthly updates
Approval Date:
22 January 2015
Amendment Date:
01/22/2014
Background:
The Dental Readiness File (DRF) outlines the dental readiness status of Active Duty Service Members (ADSM) and Guard/Reserve members, with updates from several data sources and regular monthly processing.
Year:
2006
Region / City:
Falls Church, VA
Topic:
Dental Data Exchange, Interface Control Document
Document Type:
Technical Specification
Organization:
EIDS Program Office
Author:
Lt Col Janet L. Wilson, USAF
Target Audience:
EIDS Program Office personnel, MMSO personnel
Period of validity:
Ongoing (subject to changes)
Approval Date:
December 19, 2006
Modification Date:
None specified
Note:
Year
Topic:
Infection prevention and control in dental practice
Document type:
Guideline
Organ / institution:
Dental Board of Australia
Target audience:
Registered dental practitioners