Catalog Number

Indicates the manufacturer's catalog number so that the medical device can be identified

symbol 5.1.6 from ISO 15223‑1

Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.

Manufacturer

Indicates the medical device legal manufacturer

symbol 5.1.1 from ISO 15223‑1

Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.

EC Representative

Indicates the authorized representative in the European Community / European Union

symbol 5.1.2 from ISO 15223‑1

Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.

Swiss Representative

Authorized Representative in Switzerland

ISO 20417 Reference no. 6.1.2 d)

Medical devices — Information to be supplied by the manufacturer

UK Responsible Person

Indicates the UK Responsible Person

ISO 20417 Reference no. 6.1.2 d)

Medical devices — Information to be supplied by the manufacturer 

Lot Number

Indicates the manufacturer's batch code so that the batch or lot can be identified. Synonyms for “batch code” are “lot number”, “lot code” and “batch number”.

symbol 5.1.5 from ISO 15223‑1

Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.

Serial Number

Indicates the manufacturer's serial number so that a specific medical device can be identified

symbol 5.1.7 from ISO 15223‑1

Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.

UDI Carrier

Indicates a carrier that contains unique device identifier information

symbol 5.7.10 from ISO 15223‑1

Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.

Expiration Date

Indicates the date after which the medical device is not to be used

symbol 5.1.4 from ISO 15223‑1

Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.

Manufacturing Date

Indicates the date when the medical device was manufactured

symbol 5.1.3 from ISO 15223‑1

Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.

Temperature range to which device can be exposed

Indicates the temperature limits to which the medical device can be safely exposed

symbol 5.3.7 from ISO 15223‑1

Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.

Sterilized with Gamma Radiation

Indicates a medical device that has been sterilized using irradiation

symbol 5.2.4 from ISO 15223‑1

Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.

Caution required when using device– Refer to IFU

Indicates that caution is necessary when operating the device. Refer to IFU before use.

symbol 5.4.4 from ISO 15223‑1

Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.

Consult IFU before using

Indicates the need for the user to consult the instructions for use

symbol 5.4.3 from ISO 15223‑1

Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.

Consult eIFU using given URL before using device

Indicates location of electronic IFU

symbol 5.4.3 from ISO 15223‑1

Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.

For Prescription Use Only

Caution: Federal law restricts this device to sale by or on the order of a physician

21 CFR 801.109

n/a

Device is not safe for use in a magnetic radiation environment

An item which poses unacceptable risks to the patient, medical staff or other persons within the MR environment

ASTM F2503 Reference no. Table 2, Symbol 7.3.3;
7.4.9.1; Fig. 9

Standard Practice for Marking Medical Devices and other Items for safety in the Magnetic Resonance Environment

Do Not Reuse

Indicates a medical device that is intended for one single use only
NOTE: Synonyms for “Do not reuse” are “single use” and “use only once”.

symbol 5.4.2  from ISO 15223‑1

Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.

Do Not Re-sterilize

Indicates a medical device that is not to be resterilized

symbol 5.2.6 from ISO 15223‑1

Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.

Item is a medical device

Indicates the item is a medical device

symbol 5.7.7 from ISO 15223-1

Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.

Single sterile barrier packaging system

Indicates a single sterile barrier system

symbol 5.2.11 from ISO 15223-1

Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.

Do not use if package is damaged

Indicates a medical device that should not be used if the package has been damaged or opened and that the user should consult the instructions for use for additional information

symbol 5.2.8 from ISO 15223‑1

Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.

CE Mark

Notified Body Number (BSI NL: 2797)

‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in the applicable regulation providing for its affixing

EU 2017-745 Article 20.1; MDR Annex V paragraph 1

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices

Not manufactured with natural rubber/latex

Indicates  that the device has not been manufactured with dry natural rubber or natural rubber latex as a material of construction within the medical device itself or its packaging.

symbol  5.4.5  from ISO 15223‑1

Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.

Importer

Indicates the entity importing the medical device into the locale

symbol 5.1.8 from ISO 15223‑1

Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.