Source: http://www.rtix.com/en_us/healthcare-professionals/labeling
Timestamp: 2019-04-19 12:21:39+00:00

Document:
Labeling - RTI Surgical Holdings, Inc.
For your convenience, GS1 GTINs are available here for those RTI products that have been assigned GTINs. To accurately identify a product, refer to the product label for the product description or catalog number (REF). Email Labeling@rtix.com with any questions.
Click on the links below to download UDI inventory control sheets.
The FDA issued a “final rule” (September 24, 2013) to establish a system to adequately identify medical devices through distribution and use. This rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement. The UDI system will go into effect in stages, over a period of seven years. RTI has established a team to ensure compliance with the UDI rule within the specified timeframe. We have addressed some of the common questions below. However, if you have additional questions or need more information about the UDI transition, send your questions to Labeling@rtix.com.
What does the UDI rule include?
The label of a medical device is required to bear a UDI.
Any date on the label that should be brought to the attention of the user e.g., expiration date, date of manufacture, must be presented in the format four digit year – two digit month – two digit day (e.g., 2016-09-24).
Labelers are required to submit certain data about devices to the Global Unique Device Identifier Database (GUDID). The GUDID is administered by the FDA.
Devices intended to be used more than once and reprocessed before each use are required to bear a permanent UDI affixed to the device itself unless an exception applies.
A UDI is a numeric or alphanumeric identification code assigned to medical devices by a labeler of the device. A unique device identifier is typically comprised of two segments; a device identifier (DI) and production identifier (PI).
Which RTI products are affected by the UDI requirements?
The UDI rule applies to all medical devices. Most of RTI’s products are medical devices and subject to the UDI rule but most of the human tissue RTI processes are not medical devices and the UDI rule does not apply.
Will the GTIN be used for traceability?
For those items labeled with a GTIN, the GTIN will accurately identify the model/ version number and the labeler of that particular item. For traceability, end users should capture the GTIN and the production data/ identifiers, applicable for the specific item in question e.g. serial number, expiration date, lot number.
When a customer places an order, will anything change? Can a customer still use catalog codes?
Customers will continue to use RTI catalog codes. There will be no immediate changes to packing slips and invoices.
What should customers do with existing RTI inventory? Do we need to send inventory back to RTI for relabeling?
When will UDI be implemented?
The UDI system will go into effect in stages. The table below lists the various compliance dates originally published by the FDA. The table below does not take into account the various extensions and exceptions provided for different device classes.
2 years after publication of the final rule (September 24, 2015) The labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI. § 801.20. Dates on the labels of these devices must be formatted as required by § 801.18.
The labels and packages of class I medical devices and devices that have not been classified into class I, class II, or class III must bear a UDI. § 801.20. Dates on the labels of all devices, including devices that have been excepted from UDI labeling requirements, must be formatted as required by § 801.18.
Data for class I devices and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300. Class I stand-alone software must provide its UDI as required by § 801.50(b).
Email Labeling@rtix.com with any questions.

References: § 801
 § 801
 § 801
 § 801
 § 830
 § 801