UDI and GS1 implementation | Zimmer Biomet

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Zimmer Unique Device Identification (UDI) Regulations and GS1 Standards Implementation Center

On this page you will find the following GS1 reference information for Zimmer Biomet:

Actions and Timeline Summary
Our Label Format
Downloadable GTIN Cross Reference Sheets
GDSN Registry Instructions
Additional Resources and Contact Information

Actions and Timeline

In July 2014, Zimmer began labelling products for Class III Devices under the new UDI regulations. Class II FDASIA products will transition to the new label format using a phased approach in accordance to the FDA Compliance timeline (shown below) starting early 2015. Zimmer anticipates that all U.S. sold products will have a GTIN assigned, updated labels, and (where required) direct part marking changes completed by the FDA timeline for newly manufactured products.

Device	Label / GUDID / Date Format	Direct Mark
Class III (including class III LS/LS) Implantable Devices licensed under the PHS Act	September 24, 2014	Class III LS/LS devices must bear a permanent UDI by September 24, 2015 All other class III devices must bear a permanent UDI by September 24, 2016
Implantable (class II)	September 24, 2015	N/A
LS/LS (class II)	September 24, 2015	September 24, 2016
Class II (other than I/LS/LS)	September 24, 2016	September 24, 2018

Actions and Timeline

In July 2014, Zimmer began labelling products for Class III Devices under the new UDI regulations. Class II FDASIA products will transition to the new label format using a phased approach in accordance to the FDA Compliance timeline (shown below) starting early 2015. Zimmer anticipates that all U.S. sold products will have a GTIN assigned, updated labels, and (where required) direct part marking changes completed by the FDA timeline for newly manufactured products.

Device	Label / GUDID / Date Format	Direct Mark
Class III (including class III LS/LS) Implantable Devices licensed under the PHS Act	September 24, 2014	Class III LS/LS devices must bear a permanent UDI by September 24, 2015 All other class III devices must bear a permanent UDI by September 24, 2016
Implantable (class II)	September 24, 2015	N/A
LS/LS (class II)	September 24, 2015	September 24, 2016
Class II (other than I/LS/LS)	September 24, 2016	September 24, 2018

Class I or unclassified (other than I/LS/LS)

LS/LS = life-supporting or life-sustaining

I/LS/LS = Implantable, life-supporting or life-sustaining

Direct Mark requirements apply to products that are intended to be used more than once and intended to be reprocessed before each use. Direct mark compliance dates are in addition to label/GUDID/date format compliance dates.

Zimmer Biomet supports the FDA’s Unique Device Identification (UDI) regulations and GS1 standards for product identification. Zimmer Biomet is adhering to the compliance timelines and expectations as specified by the FDA’s final rule on UDI for implementing the appropriate elements. Further Zimmer Biomet and supports the healthcare industries adoption of the Global Location Number (GLN), Global Trade Identification Number (GTIN) and the Global Data Synchronization Network (GDSN). GHX Health ConneXionTM was selected as Zimmer Biomet’s certified data pool. Class III products are currently synchronized and available for our trading partners via the GDSN subscription process. The timeline for moving other devices classes can be found in the table below. Please note that while we are working to update all labels to be GS1 and UDI Compliant, existing inventory may have labels that are not yet compliant.

For more information, contact: zimmerstandards@zimmer.com

GS1 Reference Information

Label Format Changes

GTIN Cross Reference Sheets

For your convenience, downloadable spreadsheets for the different classed products have been provided below. To accurately identify a product, refer to the product label that contains the product description, product ID (catalog number) or GTIN information.

GDSN Registry Instructions

GDSN is an internet-based interconnecting network of data pools and a global registry, which is known as the GS1 Global Registry. The registry enables companies to exchange standardized and synchronized supply chain data with trading partners via a Global Location Number (GLN) and receive product data, such as classification category codes, publication and effective dates, and Global Trade Item Numbers (GTIN).

Additional Resources

Label Format Changes

GTIN Cross Reference Sheets

GDSN Registry Instructions

Additional Resources

Important note

To receive updates via your GSDN Service Provider, request a subscription to Zimmer Biomet per the instructions provided under GDSN Instructions.

Summary of Changes

“Use By” date label format has changed from being: YYYY-MM, to: YYYY-MM-DD GS1 Matrix Barcode Information: (01) GTIN#, (17) Expiration Date (YYMMDD), (10) Lot Number, (21) Serial Number

For further questions, contact: support@ghx.com

GHX Health ConneXionTM is a Zimmer Biomet certified GDSN Data Pool provider.

Contact Information

For questions about Zimmer’s UDI and GS1 implementation, contact: zimmerstandards@zimmer.com