In 2013, the Food and Drug Administration (FDA) released a final rule establishing a unique device identification system designed to adequately identify devices through distribution and use. The final rule requires device companies to include a Unique Device Identifier (UDI) on device labels and packages, except where the rule provides for an exception or alternative. The Unique Device Identifier (UDI) will be globally unique to each device.
For more information about UDI, GUDID data elements, or to view text of the rule, visit the FDA’s website:
GS1 is a data standards organization which develops and maintains standards for supply chains across multiple sectors, including the healthcare industry. The FDA accredited GS1 as an issuing agency to assign Unique Device Identifiers (UDIs). GS1 provides the UDIs and sets the rules for how barcodes containing those UDIs appear on packaging. As a product’s unique identifier, or Global Trade Item Number (GTIN) becomes available, it will be added to packing slips, invoices, and other documents.
In order to meet the FDA regulation, Wright will transition from Health Industry Bar Code (HIBC) to standard GS1-128 compliant barcodes on all products globally. The transition will be a running change. Until existing product inventory is depleted, there will be Wright products in circulation with either the former HIBC standard barcodes or the new GS1 standard barcodes. Customer’s inventory scanning systems may need to be configured to recognize both formats.
Wright will continue to display item numbers in human readable format on product labels. Customers may continue to use the product catalog numbers to place orders. Please note, the new GS1 barcode will not contain the Wright catalog number. If you use Wright barcodes to scan our catalog number please use the human readable item number on the label or the cross reference guide available here.