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The Unique Device Identification (UDI) System is intended to assign a unique identifier to medical devices within the United States, Europe, China, South Korea, Saudi Arabia and Taiwan. [1] It was signed into law in the US on September 27, 2007, as part of the Food and Drug Administration Amendments Act (Section 226) of 2007 .
Stryker Corporation is an American multinational medical technologies corporation based in Kalamazoo, Michigan. [2] Stryker's products include implants used in joint replacement and trauma surgeries; surgical equipment and surgical navigation systems; endoscopic and communications systems; patient handling and emergency medical equipment; neurosurgical, neurovascular and spinal devices; as ...
The GMDN is part of the 'minimum data set' of the US FDA [4] Unique Device Identification regulation for the registration of new Medical Devices intended for use in the United States. This follows the international consensus [5] established by the International Medical Device Regulators Forum (IMDRF). [6]
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Tangible items are distinguished from one another by the assignment of a unique identifier in the form of a unique data string and encoded in a bar code placed on the item. An item unique identifier is only assigned to a single item and is never reused. Once assigned to an item, the IUID is never changed even if the item is modified or re ...
The IAB uses a MA-L (and OUI) belonging to the IEEE Registration Authority, concatenated with 12 additional IEEE-provided bits (for a total of 36 bits), leaving only 12 bits for the IAB owner to assign to their (up to 4096) individual devices. An IAB is ideal for organizations requiring not more than 4096 unique 48-bit numbers (EUI-48).
A similar database is the Global Unique Device Identification Database (GUDID) of the FDA. As a key to EUDAMED, the MDR introduces the Basic UDI-DI as unique device identifier. A medical device (including system- and procedure packs and IVD) needs to have an assigned Basic UDI-DI and needs to be registered in the UDI/Device part of EUDAMED.
Stryker now expects organic net sales growth for 2024 to be in the range of 8.5% to 9.5%, compared with its earlier projected range of 7.5% to 9%. Stryker lifts 2024 profit forecast on strong ...