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

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
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)

September 24, 2018

September 24, 2020

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.

GS1 Reference Information