Source: https://www.rtix.com/en_us/about/labeling
Timestamp: 2020-08-13 16:48:58
Document Index: 276211297

Matched Legal Cases: ['§ 801', '§ 801', '§ 801', '§ 801', '§ 830', '§ 801']

Labeling - RTI Surgical
GS1 Global Trade Item Number (GTIN) Search
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.
Model/Version #
UDI Inventory Control Sheet Download
Click on the links below to download UDI inventory control sheets.
Aspect UDI Inventory Sheet
CervAlign UDI Inventory Sheet
Cequence UDI Inventory Sheet
Contact ALP UDI Inventory Sheet
Lat-Fuse UDI Inventory Sheet
PAC Plate UDI Inventory Sheet
Quantum MIS UDI Inventory Sheet
Quantum UDI Inventory Sheet
Release Laminoplasty UDI Inventory Sheet
Slimfuse UDI Inventory Sheet
Streamline MIS UDI Inventory Sheet
Streamline OCT UDI Inventory Sheet
Streamline TL UDI Inventory Sheet
Tritium UDI Inventory Sheet
ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied
Authorized Representative in the European Community Indicates the Authorized Representative in the European Community. ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.1.2
Date of Manufacture Indicates the date of manufacture. This symbol is accompanied by a date. ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.1.3
Use-by Date Indicates the date after which the medical device is not to be used. ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.1.4
Batch Code Indicates the manufacturer's batch code so that the batch or lot can be identified NOTE: Synonyms for "batch code" are "lot number" and "batch number" ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.1.5
Catalog Number Indicates the manufacturer's catalog number so that the medical device can be identified NOTE: Synonyms for "catalogue number" are "reference number" and "reorder number" ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.1.6
Serial Number Indicates the manufacturer's serial number so that a specific medical device can be identified ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.1.7
Indicates a medical device that has been subjected to a sterilization process
ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.2.1
Sterilized Using Aseptic Processing Techniques Indicates a medical device that has been sterilized using aseptic processing techniques. ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.2.2
Sterilized Using Ethylene Oxide Indicates a medical device that has been sterilized using ethylene oxide. ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.2.3
Sterilized Using Irradiation Indicates a medical device that has been sterilized using irradiation. ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.2.4
Do Not Resterilize Indicates a medical device that is not to be resterilized. ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.2.6
Non-Sterile Indicates a medical device that has not been subjected to a sterilization process. ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.2.7
Do Not Use if Package is Damaged Indicates a medical device that should not be used if the package has been damaged or opened. ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.2.8
Keep Away from Sunlight Indicates a medical device that needs protection from light sources. ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.3.2
Keep Dry Indicates a medical device that needs to be protected from moisture. ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.3.4
Lower Limit of Temperature Indicates the lower limit of temperature to which the medical device can be safely exposed. ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.3.5
Upper Limit of Temperature Indicates the upper limit of temperature to which the medical device can be safely exposed. ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.3.6
Temperature Limit Indicates the temperature limits to which the medical device can be safely exposed. ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.3.7
Do Not Reuse Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure. ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.4.2
Indicates the need for the user to consult the instructions for use. ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.4.3
Electronic IFU indicator Consult instructions for use for an electronic instruction for use ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied A.15
Caution Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself. ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.4.4
Contains Or Presence Of To indicate that the equipment contains the identified product or substance. ISO 7000/IEC 60417 Graphical Symbols for Use on Equipment 2725
U.S. Food and Drug Administration (FDA) Unique Device Identification Rule
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).
A DI is a mandatory, fixed portion of the UDI that identifies the labeler and the specific model or version of the device e.g., Global Trade Item Number (GTIN)
A PI is a conditional, variable portion of the UDI e.g., lot number
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.