UDI Label Manufacturing at Thomco

Thomco Medical -UDI Labels

Unique Device Identifier (UDI) labels are a critical component for many devices, both everyday items and highly technical products. It’s equally critical to choose the right UDI label manufacturer to ensure that the information is compliant with all necessary standards.


What Are UDI Labels?

UDI labels are seen every day, and they’re fairly recognizable once you know what to look for. Labelers, as well as the labels themselves, are governed by rules laid out by the FDA.


According to these definitions, a labeler is “any person who causes a label to be applied to a device, or who causes the label of a device to be modified, with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label.” They might be part of the manufacturing company, or a manufacturer might outsource label making to an external partner. These UDI label rules require manufacturers to include a UDI on device labels and packages, as well as to submit the information to a global database, GUDID.


A label includes two types of info, in two formats. The Device Identifier, or DI, is described by FDA guidelines as “a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.” The Production Identifier, or PI, is “a conditional, variable portion of a UDI” that identifies lot or batch number, serial number, expiration date, manufacturing date, distinct identification codes for regulated devices, and other similar pieces of information. The UDI must be shown in readable plain text and in machine-readable form for Automatic Identification and Data Capture technology.

UDI labels allow for better use, reporting, and monitoring of devices. They can document device usage and document and troubleshoot device problems. The information also allows for easier location of devices that are part of a larger trend, concern, or update. It’s also a means of protecting against counterfeiting, especially for sensitive devices.


How to Choose a UDI Label Manufacturer

The ongoing readability of UDI labels is of the utmost importance. To ensure these special, high-quality labels are properly produced, printed, and adhered, it’s important to choose a manufacturer with wide-ranging and in-depth knowledge of substrates, adhesives, overlayers, inks, and how they interact with what a product will encounter: chemical resistance, climate and weather, use, daily wear and tear, and more.


A printing partner like Thomco can offer several options for substrates and adhesives in order to adhere to any material for the product and packaging. Look for a design team that can create labels that include all necessary elements, plus any branding requirements, all while remaining easy-to-read. Because of the requirement for machine-readable labels, it’s also important to partner with a manufacturer that can produce high-quality AIDC printing.


Thomco’s materials expertise means that we can put together the right solution for the individual needs of each label and product, all while also keeping track of all elements to be able to add the label’s information to the database.


UDI labels are a critical part of manufacturing a wide array of devices. To ensure compliance, longevity, and durability, partner with a label manufacturer like Thomco to handle these all-important labels.


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