Version or model

In the FDA UDI rules, each version or model has its own device identifier. A change that takes a device outside the set limits creates a new version or model with a new UDI-DI.

Version or model means all devices that have specifications, performance, size, and composition, within limits set by the labeler.

21 CFR, 830.3

Version or model means all devices that have specifications, performance, size, and composition, within limits set by the labeler.

21 CFR, 801.3