Next UDI Deadline Less Than One Month Away

29 August 2016

By September 24, 2016, the labels and packages of all Class II medical devices must bear a Unique Device Identifier (UDI), and data must be submitted to the FDA's Global Unique Device Identification Database (GUDID). 

Many medical device manufacturers are finding the process to be challenging, especially as it relates to labeling, and the timing of when to upload the data into the GUDID.

"Many companies don't realize they should update their medical device labels long before loading the data into the GUDID. Performing the labeling and GUDID activities at the same time is creating a more difficult UDI compliance process and could place companies behind pace to become compliant by the FDA-mandated deadline." - Dan O'Leary, President of Ombu Enterprises, LLC

With over 80 barcode types and pre-configured label samples, TEKLYNX' UDI label software, CODESOFT, can create complex barcodes, such as the 2D DataMatrix barcode, HIBC, and GS1 Databar required to generate UDI-compliant labels. Download a free demo:

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With the next compliance deadline just 1 month away, time is running out for manufacturers of Class II medical devices to ensure UDI compliance.

TEKLYNX' solutions provide the reliability, traceability, and security necessary when working with critical healthcare labeling. If you would like to learn more about CODESOFT or are looking for guidance on how to comply with UDI, download a demo or contact us at 414-837-4800 today!