You may be surprised by the number of different Unique Device Identifiers (UDIs) a company may need for a single type of device. A separate UDI is needed for certain variables, such as:
- Package Size
For example, if the same surgical glove was available in latex and vinyl, each glove would need its own UDI.
Registrar Corp put together the infographic below to demonstrate to industry how to determine the number of UDIs a company may need for a single device type. Registrar Corp can help medical device companies determine the UDI requirements for a particular device and submit a company’s UDI data to the GUDID. For assistance with FDA UDI requirements, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.