What exactly is a UDI? 

No doubt you have heard the term “UDI” and you may have questions about what it is and what it means to your healthcare facility. The following is a brief summary and some definitions to help you demystify UDI.

On September 24, 2013 the U.S. FDA released a final rule requiring that medical devices distributed in this country carry a Unique Device Identifier (UDI) code and that product information pertaining to the devices be submitted to the FDA's Global Device Identification Database (GUDID - Pronounced “Good I.D.”).The FDA Website states:

“FDA has established and continues to implement a unique device identification system to adequately identify medical devices through their distribution and use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form. Device labelers must also submit certain information about each device to FDA’s Global Unique Device Identification Database (GUDID). The public can search and download information from the GUDID at AccessGUDID.”

This rule also requires Direct Part Marking (DPM) on products that will be used more than once and are intended to be reprocessed before each use. Direct Part Marking can be supplied in one of three acceptable forms:

  • 2D Data Matrix
  • Linear Bar Code
  • Human Readable Code

In addition to this ruling, a new standardized date format on all medical device labels will be required. The UDI system will be phased in over several years. (Please see FDA UDI Timeline Table.)

As an example, Aesculap will supply UDI information on the product label as well as a laser etched, machine-readable data matrix that contains the Global Trade Item Number (GTIN) and other required information for products required to be direct part marked. This sample label shows the Device Identifier and Production Identifier as part of the bar code on the label.


The FDA Website indicates the benefits of UDI:

“UDI implementation will improve patient safety, modernize device post-market surveillance, and facilitate medical device innovation.”

For quick reference, following are some definitions and a timeline for when the phases of UDI will be implemented:

UDI: Unique device identifier (UDI) means an identifier (provided by the device manufacturer/labeler) that adequately identifies a device at the point of distribution and at the point of use. A unique device identifier is composed of 2 parts: Device Identifier and Production Identifier.

Device Identifier: a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device (GTIN).

Production Identifier: a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device:

  • The lot or batch within which a device was manufactured
  • The serial number of a specific device
  • The date a specific device was manufactured
  • The expiration date of a specific date
  • For a Human Cell & Tissue Products (HCT/P) regulated as a device, the distinct identification code

GTIN: The Global Trade Item Number is the globally unique Identification Number used to identify "trade items." GTINs are assigned by the brand owner (labeler) of the product, and are used to identify products as they move through the global supply chain to the hospital or ultimate end user.

GUDID: The FDA’s Global Unique Device Identification Database maintains information about each device.

DPM: Direct Part Marking means that in addition to the product label containing UDI information, the device itself must also bear a permanent marking providing the UDI information. DPM can be supplied in one of 3 acceptable forms:

  • 2D Data Matrix
  • Linear Bar Code
  • Human Readable Code

For additional information, access the following links:
FDA Website: FDA UDI Compliance
Aesculap USA Website: Aesculap UDI Information

Additional questions? Email UDI.US@aesculapusa.com




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