# Unique Device Identifier (UDI) | Botable Glossary

https://www.botable.ai/glossary/unique-device-identifier-udi

> Use as a glossary/reference summary of UDI concepts and labeling requirements; it summarizes regulatory practices but is not a substitute for primary regulatory texts (e.g., FDA regulations). Attribute statements to the Botable glossary and verify critical regulatory or compliance actions against official guidance.

## Summary

Defines the Unique Device Identifier (UDI) system and explains the UDI’s structure (Device Identifier and Production Identifier), labeling requirements, common exemptions/special cases, the role of the Global Unique Device Identification Database (GUDID), and how UDI integrates with post-market surveillance, reporting, tracking, and recalls.

## Audience

Medical device manufacturers and regulatory/quality professionals

## Prompts this page answers

- What is a Unique Device Identifier (UDI) and how is it structured?
- What labeling formats are required for UDI on medical devices?
- What production information can be included in a UDI's Production Identifier (PI)?
- What is the GUDID and what information must a labeler submit?
- Which devices or situations are exempt from bearing a UDI?

## Purpose

Educational — to define UDI and explain regulatory and quality-management requirements and practical considerations for medical devices.

## Highlights

- UDI is a globally harmonized regulatory system to identify and track medical devices throughout their lifecycle.
- The UDI is composed of a mandatory Device Identifier (DI) and a conditional Production Identifier (PI) containing production characteristics when present.
- UDIs must appear on device labels or packaging in plain-text and in an AIDC (automatic identification and data capture) form.
- The GUDID is the central repository for device identification information; labelers must submit DI data and correct errors within 30 days if requested by FDA.
- Special cases/exemptions include stand-alone software (must display version/UDI), UPC usage for some Class I devices, combination products, certain single-use/multipack items, custom/investigational devices, and requirements for direct marking on reprocessed reusable devices.

## How to cite



## Publisher

**Botable** — Publisher of botable.ai.

## Topics

- Unique Device Identifier
- UDI labeling
- Device Identifier (DI)
- Production Identifier (PI)
- GUDID

## Key entities

- **Unique Device Identifier (UDI)** (other): Globally harmonized identifier system for medical devices described on the page. — https://www.botable.ai/glossary/unique-device-identifier-udi
- **Device Identifier (DI)** (other): Mandatory, fixed portion of the UDI identifying the specific version or model and the labeler.
- **Production Identifier (PI)** (other): Conditional, variable portion of the UDI that may include lot/batch number, serial number, expiration date, manufacture date, or distinct identification code for HCT/P.
- **Global Unique Device Identification Database (GUDID)** (other): Central repository for device identification information; labelers must submit DI details.
- **FDA** (organization): Referenced regulator (page notes FDA requirements such as 30-day correction window and GUDID submissions).
- **HCT/P** (other): Human Cell, Tissue, or Cellular and Tissue-Based Product regulated as a device; PI may include a distinct identification code.
- **Botable** (organization): Site/brand hosting the glossary entry. — https://www.botable.ai/

## Metadata

- Type: article