GS1/GTIN Product Labeling

The FDA recently published their final rule on a Unique Device Identification (UDI) System for medical devices. They will require that all medical device packaging labels contain Unique Device Identifiers from FDA Accredited Issuers such as GS1. GS1 standards are the most widely used supply chain systems in the world, spanning many industries. They drive supply chain efficiency, traceability and accuracy. Examples of GS1 supply chain applications include Global Trade Item numbers (GTIN), Global Location Numbers (GLN) and the Global Data Synchronization Network (GDSN).

K2M, Inc. is implementing GS1/GTIN labeling and bar code standards as part of our continuing efforts to meet FDA UDI and other Regulatory requirements. The full conversion to the upgraded product labeling will be completed by 2015, meaning that starting 2016, only products with the upgraded product label will be shipped out from K2M Inc to its users.

GTIN Download

Download the GTIN Cross Reference File HERE.

Important information about the GTIN Cross-reference download list:

  • Active and obsolete products are included.
  • Inclusion of products within the cross-reference list does not mean that all products are available for ordering at this time nor that they are available within all markets.
  • GTINs provided are based on the Shipping Unit of Measure (UOM). We may not provide GTINs for alternate UOMs.
  • Reference the Date Added column for latest updates.


Label Details

The new product label will feature the addition of the Global Trade Item Number (GTIN) in human readable and GS1 Datamatrix format. The K2M proprietary linear bar code symbol will be removed. Note that the item part number is still present and may be found in the Reference/Catalog field of the label. Key changes are identified below.

Sterile Product Label2

K2M Inc. has determined that the benefits of implementing GS1/GTIN labeling and bar code standards as part of continuing efforts to meet FDA UDI and other Regulatory requirements outweights the potential risks that its implementation represents.

Frequently Asked Questions

K2M, Inc. is moving to the GS1/GTIN labeling and bar code standards as part of our continuing efforts to meet customer expectations and improve supply chain efficiency. This document contains answers to some of the more frequently asked questions. If you need additional information or support or would like to speak with someone regarding this activity, please contact either your sales representative or Customer Care at (866) 526-4171.

1. What are the GS1 Standards?

GS1 standards are the most widely used supply chain systems in the world, spanning many industries. They drive supply chain efficiency, traceability and accuracy. Examples of GS1 supply chain applications include Global Trade Item numbers (GTIN), Global Location Numbers (GLN) and the Global Data Synchronization Network (GDSN).

To learn more about GS1 Healthcare, please visit, www.gs1.org/healthcare.

2. What is a GTIN?

A GTIN (Global Trade Item Number) is a globally unique identification number of an item in the supply chain that identifies a product from manufacturing through distribution and use. The GTIN is typically a 14-digit numeric code which includes a company prefix followed by product identification numbers. The GTIN, as well as other key product attributes, are automatically identified when a bar code is scanned.

3. Why is K2M moving to the GS1/GTIN now?

K2M, Inc. is moving to the GS1/GTIN Healthcare Standard as part of our continuing efforts to meet customer expectations and improve supply chain efficiency. We recognize the value of standardization for the medical device industry and are working closely with healthcare providers to ensure that we are delivering what they need related to GS1 standards. In addition FDA recently published their final rule on a Unique Device Identification (UDI) System for medical devices. They will require that all medical device packaging labels contain Unique Device Identifiers from FDA Accredited Issuers such as GS1.

4. How does this change impact hospitals or distributors?

It primarily impacts hospitals and distributors that currently scan or plan to scan product label bar codes. They will need to update their materials management information systems (MMIS) with the GTIN part numbers to cross reference the K2M catalog numbers, which can be accessed via the K2M website or upon request.

5. Is the GTIN replacing the numbers and bar codes on all current products?

K2M, Inc. products are currently labeled with a Catalog Number and Lot Number with a K2M proprietary linear barcode corresponding to Catalog number and Lot number. The linear barcode will be removed but the Catalog/Lot number will remain on the label as a secondary device identifier to the GTIN and GS1 bar code.

6. What does the new label look like?

The new product label will feature the addition of the GTIN in human readable and GS1 Datamatrix format. The K2M proprietary linear bar code symbol will be removed. Note that the item part number is still present and may be found in the Reference/Catalog field of the label. Key changes are identified below.

7. Where are GTINs used?

GTINs are used on product labels.

8. What is the timeline for products transitioning to GTINs?

GTIN labeling begins in January 2015. Each month additional products will transition to the new label. We anticipate that all K2M products will include the new GTIN identifier by the end of 2015.

Over the next year, you will see a mixed inventory of products as our supply chain pipeline is flushed and previously-labeled product is consumed. There is no difference between products that are currently labeled or GTIN labeled. As such, current-labeled products need not be returned. You can still use the products regardless of the type of label attached to them.

9. Where can I get a list of GTIN bar codes?

A complete listing of our products transitioning to the GTIN part numbers along with their original part number may be found on our website.

10. Are other companies using these GS1 Standards?

Yes. Numerous companies across the healthcare industry have adopted GS1 standards.

11. How do the GS1 standards relate to the new Unique Device Identification (UDI) rule?

The FDA recently published their final rule on a Unique Device Identification (UDI) System for medical devices. They will require that all medical device packaging labels contain Unique Device Identifiers from FDA Accredited Issuers.

12. Do we have to use GTINs to order K2M products?

No. You may continue to use Catalog Numbers to order products.

13. Do I need to return inventory that doesn’t have the new GTIN labeling?

No. You may receive inventory that contains only the current product labels during the transition period to the new labeling. It is not necessary to return products that do not contain GTIN bar code labels.

14. Who can I contact for more information or help with GTIN bar code scanning?

For more information, please contact your local K2M, Inc. sales representative or our Customer Service team at (866) 526-4171.