Labeling

For your convenience, GS1 GTINs are available here for those Evegen 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.
Symbol Title Definition Standard Reference Number
grc-product-labels-manufacturer.png Manufacturer Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC. ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied
5.1.1
grc-product-labels-authorized-representative-european-community.png 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
Authorized representative in SwitzerlandIndicates the authorized representative in SwitzerlandISO 15223-1:2021, ISO 3166-15.1.2
Authorized representative in the United KingdomIndicates the authorized representative in the United KingdomISO 15223-1:2021, ISO 3166-15.1.2
grc-product-labels-date-manufacture.png 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
grc-product-labels-use-by-expiration-date.png 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
grc-product-labels-batch-code-lot-number.png 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
grc-product-labels-catalog-reorder-reference-number.png 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
grc-product-labels-serial-number.png 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
grc-product-labels-sterile.png Sterile

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
grc-product-labels-sterilized-using-aseptic-processing-techniques.png 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
grc-product-labels-sterilized-using-ethylene-oxide.png 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
grc-product-labels-sterilized-using-irradiation.png 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
grc-product-labels-do-not-resterilize.png 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
grc-product-labels-symbol-nonsterile.png 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
grc-product-labels-do-not-use-package-damaged.png 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
grc-product-labels-keep-away-sunlight.png 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
grc-product-labels-keep-dry.png 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
grc-product-labels-lower-limit-temperature.png 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
grc-product-labels-upper-limit-temperature.png 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
grc-product-labels-temperature-limitation-temperature-range.png 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
grc-product-labels-do-not-reuse-single-use-only.png 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

grc-product-labels-consult-instructions-for-use.png Consult Instructions For Use
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
eifu-indicator.png?mtime=20170703141510#asset:2088:url 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
grc-product-labels-caution.png 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
grc-product-labels-contains-or-presence-of.png 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
UKCA markingTo demonstrate compliance with UK regulations of devices placed on the market in Great BritainUK MDR SI 2002 No 618
Self-Tapping ScrewTo indicate self-tapping screwN/A, Resolve-created symbol
Self-Drilling ScrewTo indicate self-drilling screwN/A, Resolve-created symbol

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 went into effect in stages, over a period of seven years. Evergen 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., 2024-09-24). 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.

What is a UDI?
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 Evergen’s products are medical devices and subject to the UDI rule but most of the human tissue Evergen 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 Evergen catalog codes. There will be no immediate changes to packing slips and invoices.

What should customers do with existing Evergen inventory?
Do we need to send inventory back to Evergen for relabeling?

Devices that are in commercial distribution prior to the applicable compliance date do not have to comply with the final rule.

When was UDI implemented?
The UDI system went into effect in 7 stages. The final stage was completed on September 24, 2020. Various extensions and exceptions may be provided for different device classes.

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