91制片厂

91制片厂 Unique Device Identification (UDI) Regulations and GS1 Standards Implementation Center

Here you will find the following GS1 reference information for 91制片厂:

91制片厂 supports the FDA鈥檚听Unique Device Identification听(UDI) regulations and GS1 standards for product identification. 91制片厂 is adhering to the compliance timelines and expectations as specified by the FDA鈥檚 final rule on UDI for implementing the appropriate elements.

Further 91制片厂 and supports the healthcare industries adoption of the听Global Location Number听(骋尝狈),听Global Trade Identification Number听(GTIN) and the听Global Data Synchronization Network听(骋顿厂狈).

GHX Health ConneXionTM听was selected as 91制片厂鈥檚 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.听

Contact: 听听zimmerstandards@zimmer.com

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Actions and Timeline

In July 2014, 91制片厂 began labeling 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. 91制片厂 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.听

Device

Label/GUDID/Date Format

Direct Mark (When Required)

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.

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Label Format

A comparison of the old and new labels and patient stickers are below.

Summary of Changes:

鈥淯se By鈥 Date format changed:

听听听听From: YYYY-MM听听 To: YYYY-MM-DD

GS1 Matrix Barcode Information:

听听听听(01) GTIN#

听听听听(17) Expiration Date (YYMMDD)

听听听听(10) Lot Number

听听听听(21) Serial Number (if aplicabale)

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Downloadable GTIN Cross Reference Sheets

For your convenience, downloadable spreadsheets for the different classed products have been provided below.听

To accurately identify a product, refer to the product label that contains the product description, product ID (catalog number) or GTIN information.

IMPORTANT NOTE: To receive updates via your GSDN Service Provider, request a subscription to 91制片厂 per the instructions provided under听听GDSN Instructions.

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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).

The steps to access 91制片厂 data on the GDSN are as follows:

  1. Establish a GDSN trading partner account with a GS1 certified GDSN Data Pool provider.
  2. Submit a subscription request for 91制片厂 Product Information (91制片厂鈥檚 GLN: 0885836000000).
  3. Email your GLN to听zimmerstandards@zimmer.com听to ensure the subscription request has been received and processed.

Once the steps above are complete, the request will be accepted or rejected.听 If accepted, the data is available to automatically import into the providers material management system.

After deciding to accept or reject a products data, 91制片厂 will receive a notification regarding future product data requests.

GHX Health ConneXionTM听is 91制片厂鈥檚 certified GDSN Data Pool provider.听 GHX鈥檚 contact information is provided below.

Global Healthcare Exchange (GHX)
5:00 a.m.鈥 6:00 p.m., Mountain Time, Monday to Friday
1.800.YOUR.GHX (1.800.968.7449)
support@ghx.com

Additional Resources and Contact Information

For questions about 91制片厂鈥檚 UDI and GS1 implementation, contact听zimmerstandards@zimmer.com.

Helpful Links:

  • FDA Medical Device/UDI
  • FDA Global UDI Database (GUDID) Guidance
Legal Disclaimer

All content herein is protected by copyright, trademarks and other intellectual property rights, as applicable, owned by or licensed to 91制片厂 or its affiliates unless otherwise indicated, and must not be redistributed, duplicated or disclosed, in whole or in part, without the express written consent of 91制片厂. 鈥

This material is intended for health care professionals. Distribution to any other recipient is prohibited.听

For product information, including indications, contraindications, warnings, precautions, potential adverse effects and patient counseling information, see the听instructions for use or contact your local representative; search this website for additional product information.听To obtain a copy of the current Instructions for Use (IFU) for full prescribing and risk information, please visit .听For product related questions, please call 1-800-348-2759.听