Unique Device Identifier

Are you familiar with the term UDI? It stands for Unique Device Identifier. If you sell to the medical device market, this is a term you are sure to be familiar with, along with implementation requirements and dates issued by the FDA regarding implementation for labeling medical devices.

What does the FDA consider a "medical device"?

The Access GUDID portal, which was created to make UDI information available to everyone through a collaboration of the National Library of Medicine and the FDA, defines medical device as follows:

"Medical devices cover a wide range of products - implants, CT scanners, surgical instruments, contact lenses, wheelchairs, and blood glucose tests, to name a few. Unlike drugs, many medical devices currently do not have a unique identifier that clearly distinguishes one product from another. But this is changing. The UDI system will provide a consistent and standard way to identify medical devices throughout their distribution and use by health care providers and patients."

Link to Access GUDID

Shown below is a fictitious medical device label showing key data elements as displayed on the Access GUDID portal.

For additional information we have provided the following link. FDA UDI Basics

BarcodeFactory can supply you with the correct barcode scanning or RFID equipment and the proper label and adhesive combination for medical device labeling and other variable information labels that meet your needs for any healthcare requirement.