What Is GS1?

MicroPort complies with UDI requirements through the GS1 system of standards which provides a more efficient and responsive way of trading to our customers.  Distinct numbers are used in this system to identify goods, services, assets and locations worldwide. These numbers can be represented in barcodes to enable their electronic reading wherever required in business processes.

GS1 Identification Keys include:

  • GTIN – Global Trade Item Number for product identification
  • GLN – Global Location Number for identification of corporate entities, functional departments, and physical locations (MicroPort locations)

Adoption of GS1 in the health care industry is intended to:

  • Enhance traceability, fight counterfeiting and facilitate authentication systems
  • Strengthen product recalls
  • Improve supply chain efficiency
  • Enable AIDC (bar code) systems all the way from manufacturing to the point of care
  • Facilitate health care provider initiatives to fulfill Center for Medicare Services meaningful use requirements
  • Reduce medical errors
  • Provide global support for product registration and notifications

For more information about GS1 standards, access the GS1 global site: https://www.gs1.org/.

GTIN Cross Reference Catalog

When GS1 labels are not present, UDI information can be derived by combining part numbers or descriptions of devices with a cross referencing tool.

Listed below are multiple ways to obtain a device’s GTIN from its catalog numbers or descriptions when labels are not present.

  1. Download GTIN Cross Reference Catalog (Spreadsheet) directly below and search by catalog number.
    Note: Products listed may not be available for ordering within all markets.
  2. Email UDI@ortho.microport.com to have a UDI Cross Reference sheet emailed directly to your inbox. Enter the sales order number, kit catalog number, or device catalog number in the subject field (separate multiple items by commas or semicolons).
  3. Call your Service or Sales Representative to have a UDI Cross Reference sheet mailed to your location or emailed directly to your inbox.

GTIN Cross Reference Catalog

Prophecy GTIN Cross Reference Catalog

GTIN Labeling Changes

MicroPort began placing GTIN barcodes on labeling in June 2019.  Please note that previously existing inventory may have labels that are not yet compliant.

The images below compare MicroPort labels before and after the addition of GS1 barcodes.

MicroPort Orthopedics' Pre-GS1 Label MicroPort Orthopedics' Post-GS1 Label
Pre GS1 Post GS1

 

Direct Part Marking

Direct Part Marking requires the UDI (GTIN) be permanently added to reusable and reprocessed devices at the point of manufacture.

More specifically, a medical device must have a Direct Part Marking if the three requirements below are met:

  1. The UDI is required on the device label
  2. The device is intended to be used more than once
  3. The device is reprocessed before each use

This will enable traceability of these devices after they are separated from their labeling or packaging.

Class I reusable devices make up the majority of our products that need to be marked.

The FDA deadline for new inventory Class I reusable devices is September of 2020. The FDA deadline for existing inventory for Class I reusable devices is September of 2023.

 

Construct HIBCC UDI

MicroPort Orthopedic’s reusable instruments are directly marked with the part number and lot number.

These two values can be used to construct the UDI DI (device identifier) and UDI PI (production identifier).

The DI can be constructed using the part number and the PI uses the lot number.

No additional PI elements are associated to the reusable instruments, other than the lot number.

  1. Identify part number on the instrument.

    Example: E5002001

  2. Construct UDI DI based on the following format M684 + [PART NUMER] + 1.

    Example: UDI DI M684E50020011

  3. Identify lot number.

    Example: ABC124

  4. The UDI PI will be the lot number. No additional PIs are associated to reusable instruments for MPO.

    Example: UDI PI ABC124