{"product_id":"gudid-udi-setup-510k","title":"GUDID \u0026 UDI Setup","description":"\u003cstyle\u003e\n  .cn-service-content {\n    color: #000000;\n    font-size: 16px;\n    line-height: 1.75;\n  }\n\n  .cn-service-content h2,\n  .cn-service-content h3,\n  .cn-service-content p,\n  .cn-service-content li,\n  .cn-service-content strong {\n    color: #000000;\n  }\n\n  .cn-service-content h2 {\n    font-size: 25px;\n    line-height: 1.4;\n    margin: 30px 0 14px;\n  }\n\n  .cn-service-content h3 {\n    font-size: 19px;\n    margin: 22px 0 10px;\n  }\n\n  .cn-service-content p {\n    margin: 0 0 16px;\n  }\n\n  .cn-service-content ul,\n  .cn-service-content ol {\n    padding-left: 24px;\n    margin: 0 0 22px;\n  }\n\n  .cn-service-content li {\n    margin-bottom: 9px;\n  }\n\n  .cn-service-content .cn-note {\n    border: 1px solid #dddddd;\n    padding: 18px;\n    margin-top: 24px;\n  }\n\n  @media (max-width: 600px) {\n    .cn-service-content h2 {\n      font-size: 22px;\n    }\n  }\n\u003c\/style\u003e\n\u003cdiv class=\"cn-service-content\"\u003e\n\u003ch2\u003eGUDID \u0026amp; UDI Setup Services for Medical Device Manufacturers\u003c\/h2\u003e\n\u003cp\u003eAre you preparing to market a medical device in the United States and need support with Unique Device Identification (UDI) and the FDA's Global Unique Device Identification Database (GUDID)? The GUDID \u0026amp; UDI Setup service from Cosmetic Compliance Nest helps medical device businesses organise device identification information, review applicable labelling requirements, and prepare relevant database data.\u003c\/p\u003e\n\u003cp\u003eUDI and GUDID requirements play an important role in medical device identification and traceability. Depending on the device and applicable regulatory requirements, manufacturers and other responsible labelers may need to assign a UDI, include the required identifier on device labelling, and submit relevant device information to GUDID.\u003c\/p\u003e\n\u003cp\u003eOur service provides structured support for reviewing device information, preparing applicable database fields, and understanding the steps involved in UDI and GUDID compliance for the US market.\u003c\/p\u003e\n\u003ch2\u003eWhat Are UDI and GUDID?\u003c\/h2\u003e\n\u003cp\u003eA \u003cstrong\u003eUnique Device Identifier (UDI)\u003c\/strong\u003e is a device identification code used to identify a medical device. It generally consists of a Device Identifier (DI) and, where applicable, a Production Identifier (PI).\u003c\/p\u003e\n\u003cp\u003eThe Device Identifier identifies the specific device labeler and device version or model. The Production Identifier may include production-related information, such as a lot or batch number, serial number, expiration date, or manufacturing date, where applicable.\u003c\/p\u003e\n\u003cp\u003eThe \u003cstrong\u003eGlobal Unique Device Identification Database (GUDID)\u003c\/strong\u003e is maintained by the US Food and Drug Administration (FDA). It contains the DI and key identifying information about medical devices subject to applicable requirements. GUDID does not store the actual production identifier values.\u003c\/p\u003e\n\u003ch2\u003eWhat Does Our GUDID \u0026amp; UDI Setup Service Cover?\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eInitial Requirements Assessment:\u003c\/strong\u003e Review available device details to help determine the applicable UDI and GUDID requirements and identify potential exceptions or alternatives for further consideration.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDevice Identifier Guidance:\u003c\/strong\u003e Provide guidance on the DI and relevant issuing-agency considerations for the applicable device.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eGUDID Data Preparation:\u003c\/strong\u003e Help organise the device information required for relevant GUDID data fields, based on the device and agreed scope.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDevice Information Review:\u003c\/strong\u003e Review details such as the device name, model or catalogue number, labeler information, and other applicable identifying attributes.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePackaging and Configuration Review:\u003c\/strong\u003e Help assess relevant device packaging levels and configurations where these affect the identification and database information requirements.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUDI Labelling Guidance:\u003c\/strong\u003e Review applicable requirements for presenting UDI information in human-readable and machine-readable formats, subject to the device's regulatory requirements.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eGUDID Submission Preparation:\u003c\/strong\u003e Assist with organising data and preparing the information needed for database submission, within the agreed service scope.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eData Consistency Review:\u003c\/strong\u003e Check the consistency of available device identification information against the documentation provided by the client.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRecord Maintenance Guidance:\u003c\/strong\u003e Explain relevant considerations for maintaining or updating applicable GUDID records when device information changes.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eThe precise scope depends on the device, the responsible labeler, the information available, account access, and the services agreed before work begins.\u003c\/p\u003e\n\u003ch2\u003eWho Should Consider This Service?\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003eMedical device manufacturers planning to enter the US market.\u003c\/li\u003e\n\u003cli\u003eForeign manufacturers supplying medical devices to the United States.\u003c\/li\u003e\n\u003cli\u003eDevice labelers responsible for applicable UDI and GUDID obligations.\u003c\/li\u003e\n\u003cli\u003eBusinesses preparing device identification data for a new medical device.\u003c\/li\u003e\n\u003cli\u003eCompanies reviewing existing UDI labels or GUDID records.\u003c\/li\u003e\n\u003cli\u003eMedical device businesses managing multiple models, packaging levels, or product configurations.\u003c\/li\u003e\n\u003cli\u003eOrganisations seeking guidance on applicable FDA device identification requirements.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003eOur GUDID \u0026amp; UDI Setup Process\u003c\/h2\u003e\n\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eInitial Assessment:\u003c\/strong\u003e Review your device type, available product information, manufacturer or labeler details, and intended US market activities.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRequirements Review:\u003c\/strong\u003e Identify the relevant UDI and GUDID requirements for assessment, including potentially applicable exceptions or alternatives.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eInformation Collection:\u003c\/strong\u003e Organise the device identification details and supporting information required for the agreed work.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUDI and Labelling Review:\u003c\/strong\u003e Review applicable identifier and labelling information based on the available documentation and agreed scope.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eGUDID Data Preparation:\u003c\/strong\u003e Help prepare the applicable device information for database entry or submission.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eQuality and Consistency Check:\u003c\/strong\u003e Review the prepared information for inconsistencies or missing details that can be identified from the supplied records.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSubmission Support:\u003c\/strong\u003e Provide the agreed level of guidance or assistance with the GUDID submission process, subject to the required access and permissions.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFinal Review:\u003c\/strong\u003e Where included in the package, review the available submission status or published record details.\u003c\/li\u003e\n\u003c\/ol\u003e\n\u003ch2\u003eBenefits of Professional UDI and GUDID Support\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eBetter Data Organisation:\u003c\/strong\u003e Structure device identification information before preparing a database record.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eImproved Information Consistency:\u003c\/strong\u003e Identify potential discrepancies between supplied product information and prepared GUDID data.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eClearer Regulatory Understanding:\u003c\/strong\u003e Develop a better understanding of applicable UDI, database, and labelling requirements.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eMore Structured Preparation:\u003c\/strong\u003e Follow an organised process for collecting and reviewing relevant device information.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSupport for US Market Planning:\u003c\/strong\u003e Understand the device identification tasks that may form part of broader regulatory preparation.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRecord Maintenance Awareness:\u003c\/strong\u003e Understand the importance of reviewing and maintaining applicable device identification records when changes occur.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003eDocuments and Information You May Need\u003c\/h2\u003e\n\u003cp\u003eDepending on your device and the agreed service scope, the following information may be requested:\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eDevice name and product description.\u003c\/li\u003e\n\u003cli\u003eManufacturer and responsible labeler details.\u003c\/li\u003e\n\u003cli\u003eModel, catalogue, or reference numbers.\u003c\/li\u003e\n\u003cli\u003eExisting DI or UDI information, if already assigned.\u003c\/li\u003e\n\u003cli\u003eDetails of device packaging levels and configurations.\u003c\/li\u003e\n\u003cli\u003eApplicable device classification and regulatory information.\u003c\/li\u003e\n\u003cli\u003eProduct labels, artwork, or relevant packaging information.\u003c\/li\u003e\n\u003cli\u003eInformation about lot or batch numbers, serial numbers, expiration dates, or other applicable production identifiers.\u003c\/li\u003e\n\u003cli\u003eExisting GUDID record details, where applicable.\u003c\/li\u003e\n\u003cli\u003eRelevant account access or authorisation needed for submission support, where agreed.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eNot every item will be required for every device. The necessary information depends on the applicable regulatory requirements, device characteristics, and the agreed scope of work.\u003c\/p\u003e\n\u003ch2\u003eUnderstanding UDI and GUDID Requirements\u003c\/h2\u003e\n\u003cp\u003eUDI and GUDID are related but serve different purposes. UDI concerns the identification of a medical device and its applicable labelling requirements, while GUDID is the database used to maintain key device identification information.\u003c\/p\u003e\n\u003cp\u003eRequirements can vary depending on the device, its regulatory status, the responsible labeler, and applicable exceptions or alternatives. The issuing agency, identifier assignment, label requirements, database submission, and record maintenance should be considered as part of the overall compliance process.\u003c\/p\u003e\n\u003cp\u003eA GUDID record does not replace other applicable FDA requirements. Depending on the device, separate obligations relating to establishment registration, device listing, premarket notification or approval, quality management, and other regulatory matters may also apply.\u003c\/p\u003e\n\u003ch2\u003eFrequently Asked Questions About GUDID \u0026amp; UDI Setup\u003c\/h2\u003e\n\u003cp\u003eVisit our dedicated Frequently Asked Questions page for more information about UDI requirements, GUDID data preparation, device labelling, submission support, and medical device regulatory considerations.\u003c\/p\u003e\n\u003ch2\u003ePrepare Your Device Identification Information\u003c\/h2\u003e\n\u003cp\u003eOrganise your medical device identification information with support from \u003cstrong\u003eCosmetic Compliance Nest\u003c\/strong\u003e. Our GUDID \u0026amp; UDI Setup service helps businesses review applicable requirements, prepare relevant device data, and plan the next steps for database and labelling activities.\u003c\/p\u003e\n\u003cdiv class=\"cn-note\"\u003e\n\u003ch3\u003eImportant Disclaimer\u003c\/h3\u003e\n\u003cp\u003eCosmetic Compliance Nest provides independent regulatory consultancy and documentation support. It is not affiliated with or endorsed by the US Food and Drug Administration (FDA) or any UDI issuing agency. UDI and GUDID obligations depend on the device and applicable regulatory requirements, including any relevant exceptions or alternatives. This service does not guarantee FDA clearance, approval, registration acceptance, GUDID publication, or a particular compliance outcome. The client remains responsible for the accuracy of supplied information and for meeting applicable regulatory obligations. Issuing-agency fees, barcode generation, label artwork changes, account fees, and third-party charges are excluded unless expressly included in the agreed service terms.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e","brand":"Spectra Cosmetic Compliance","offers":[{"title":"Up to 10 SKUs","offer_id":51539745079463,"sku":null,"price":153791.0,"currency_code":"PKR","in_stock":true},{"title":"per extra device","offer_id":51539745112231,"sku":null,"price":55454.0,"currency_code":"PKR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0768\/9496\/1831\/files\/laboratory_4.png?v=1792312055","url":"https:\/\/www.cosmeticcompliancenest.com\/products\/gudid-udi-setup-510k","provider":"Nest Qual","version":"1.0","type":"link"}