Reference Information

 

UDI Labeling Symbols

  • SYMBOL TITLE: MANUFACTURER

    Explanatory Text: Indicates the medical device manufacturer

    Standard Reference: ISO 15223-1, Clause 5.1.1

  • SYMBOL TITLE: DO NOT RESTERILIZE

    Explanatory Text: Indicates a medical device that is not to be resterilized.

    Standard Reference: ISO 15223-1, Clause 5.2.6

  • SYMBOL TITLE: BATCH CODE

    Explanatory Text: Indicates the manufacturer’s batch code so that the batch or lot can be identified.

    Standard Reference: ISO 15223-1, Clause 5.1.5

  • SYMBOL TITLE: CATALOGUE NUMBER

    Explanatory Text: Indicates the manufacturers catalogue number so that the medical device can be identified.

    Standard Reference: ISO 15223-1, Clause 5.1.6

  • SYMBOL TITLE: STERILIZED USING IRRADIATION

    Explanatory Text: Indicates a medical device that has been sterilized using irradiation.

    Standard Reference: ISO 15223-1, Clause 5.2.4

  • SYMBOL TITLE: STERILIZED USING ETHYLENE OXIDE

    Explanatory Text: Indicates a medical device that has been sterilized using ethylene oxide.

    Standard Reference: ISO 15223-1, Clause 5.2.3

  • SYMBOL TITLE: DO NOT USE IF PACKAGE IS DAMAGED

    Explanatory Text: Indicates a medical device that should not be used if the package has been damaged or opened.

    Standard Reference: ISO 15223-1, Clause 5.2.8

  • SYMBOL TITLE: DO NOT REUSE

    Explanatory Text: Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.

    Standard Reference: ISO 15223-1, Clause 5.4.2

  • SYMBOL TITLE: KEEP AWAY FROM SUNLIGHT

    Explanatory Text: Indicates a medical device that needs protection from light sources.

    Standard Reference: ISO 15223-1, Clause 5.3.2

  • SYMBOL TITLE: USE-BY DATE

    Explanatory Text: Indicates the date after which the medical device is no to be used.

    Standard Reference: ISO 15223-1, Clause 5.1.4

  • SYMBOL TITLE: CONSULT INSTRUCTIONS FOR USE

    Explanatory Text: Indicates the need for the user to consult the instructions for use.

    Standard Reference: ISO 15223-1, Clause 5.4.3

  • SYMBOL TITLE: NON-PYROGENIC

    Explanatory Text: Indicates a medical device that is non-pyrogenic.

    Standard Reference: ISO 15223-1, Clause 5.6.3

  • SYMBOL TITLE: KEEP DRY

    Explanatory Text: Indicates a medical device that needs to be protected from moisture.

    Standard Reference: ISO 15223-1, Clause 5.3.4

  • SYMBOL TITLE: PRESCRIPTION ONLY

    Explanatory Text: Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.

    Standard Reference: US FDA Guidance: Alternative to Certain Prescription Device Labeling Requirements.

  • SYMBOL TITLE: TEMPERATURE LIMIT

    Explanatory Text: Indicates the temperature limits to which the medical device can be safely exposed.

    Standard Reference: ISO 15223-1, Clause 5.3.7

  • SYMBOL TITLE: CAUTION

    Explanatory Text: 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.

    Standard Reference: ISO 15223-1, Clause 5.4.4