Device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. Distinct identification code required by §1271.290 (c) for...

Include a unique device identifier (UDI), issued under an FDA-accredited issuing agency's UDI system, on device labels, device packages, and in some instances, directly on the device.

According to the U.S. FDA, when fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form, which will ultimately improve patient safety, modernise device postmarket surveillance, and facilitate medical device innovation.

2023年8月21日 · The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI).

2024年7月30日 · The unique device identification (UDI) is a unique numeric or alphanumeric code related to a medical device. It allows for a clear and unambiguous identification of specific devices on the market and facilitates their traceability.

2024年12月17日 · AccessGUDID is a searchable database of device identification information, such as the device identifier on the label, device name, company name, MR safety status, Global Medical Device...

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 .

2017年3月24日 · How to create a UDI code? A UDI code aims at unambiguous identification of a specific medical device. To ensure a globally standardized and harmonized system, the UDI code must be issued under the rules of a U.S. FDA-accredited issuing agency or an EU-accredited assigning agency, which includes GS1. The UDI code is a unique, alphanumeric code ...

Unique Device Identification (UDI) System. Introduction to the new UDI system and the obligations of operators. The existing regulatory framework on medical devices dates back to the 1990s and consists of three Directives.

The GS1 UDI barcode combines the Device Identifier (DI), also known as the GTIN by GS1.org, and the Production Identifier (PI).