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