FDA is establishing a unique device identification system to adequately identify medical devices through their distribution and use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form.
Spine Wave has chosen GS1 Standards, implementing Global Trade Item Numbers(GTINs) to uniquely identify all of its products.
GS1, a leading global standards organization, is an FDA-Accredited Issuing Agency for unique device identifiers (UDIs). Global GS1 Standards, administered in the U.S. by GS1 US, are authorized for use by manufacturers to address requirements of the new FDA UDI regulation. For more information and for the full text of the rule, visit the FDA’s website: FDA.gov/MedicalDevices.
Please click on the links to get a copy of the Inventory Control Sheet that includes Item Code, Item Description and GTIN information.
