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Label Changes

Label Changes
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Stryker Product Label Changes The healthcare industry is changing rapidly. We recognize that organizations are being challenged to improve patient safety and quality of care while lowering costs, increasing efficiencies, and adapting to new regulations. To support these initiatives, Stryker is updating our product labels to include barcodes that conform to standards created by GS1. GS1 develops and maintains standards for supply and demand chains across multiple sectors, including the healthcare industry. With this transition, Stryker will support visibility across the entire supply chain, enabling consistent information transfer from manufacturing sites to hospitals, clinics, and patient treatment centers. GS1 barcodes support: • Improved inventory management and supply chain efficiencies • US Food and Drug Administration’s (FDA’s) Unique Device Identification (UDI) final rule which specifies the use of a unique number and standardized barcode on all medical products • Integration of device usage information into computer data systems and electronic patient records • Reduced medical errors caused by the incorrect identification of products • Faster identification of medical devices associated with adverse events or recalls • Better detection of counterfeit devices # Stryker Products impacted Class III* (high risk) Medical Devices** All other implantable, life supporting, life sustaining medical devices All Other Class II (critical) Medical Devices All Other Class I (non-critical) Medical and Unclassified Devices * tryker is following the U.S. FDA compliance deadline to assign a Unique Device Identifier to applicable products, which will be incorporated into product label barcodes based on the FDA’s medical S device classification. ** Estimated timeline for when newly manufactured product will bear

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What is changing? GS1 barcodes: • ver the next few years, you will start to see O new GS1 barcode labels on Stryker products. Most product labels will bear a linear barcode, however, due to space limitation, some product labels may ship with a two barcode format or a DataMatrix (2D) barcode. • s they become available, a product’s unique A identifier, or Global Trade Item Number (GTIN), will be added to packing slips, invoices and other documents. • tryker will continue to take orders, manage S service requests, and conduct business using product catalog numbers, however, in most cases you...

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Label Changes 2Pages

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Label Changes
2Pages