5.1.1

Manufacturer

Indicates the medical device manufacturer.

5.1.2

Authorized representative inthe European community

Indicates the authorized representative in the European Community / European Union.

5.1.3

Date of manufacture

Indicates the date when the medical device was manufactured

5.1.4

Use-by date

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

5.1.5

Batch code

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

5.1.6

Catalogue number

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

5.2.3

Sterilized using ethylene oxide

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

5.2.4

Sterilized using irradiation

Indicates a medical device that has been sterilized using irradiation.

5.2.6

Do not resterilize

Indicates a medical device that is not to be resterilized

5.2.7

Non-sterile

Indicates a medical device that has not been subjected to a sterilization process.

5.2.8

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

5.2.11

Single Sterile barrier system

Indicates a single sterile barrier system.

5.2.14

Single sterile barrier system with protective packaging outside

Indicates a single sterile barrier system with protective packaging outside.

5.3.7

Temperature Limit

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

5.3.8

Humidity Limitation

Indicates the range of humidity to which the medical device can be safely exposed.

5.4.2

Do not re-use

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”.

5.4.3

Consult instructions for use

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

5.4.4

Caution

To indicate that caution is necessary when operating the device or control close to where the symbol is placed, or to indicate that the current situation needs operator awareness or operator action in order to avoid undesirable consequences.

FDAUse of Symbols in Labeling

Prescription Use Only

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

EU MDR2017/745

Medical Device

Indicates the device is a medical device.

DIRECTIVE 2012/19/EU
Annex II, Section 8

WEEE Label

Indicates that the product should not be discarded as unsorted waste but must be sent to separate collection facilities for recovery and recycling.

ABBREVIATIONS

MR Unsafe

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

ASTM F2503 7.3.3

Quantity

Quantity of devices in package.

IEC 60417

Alternating Current

IEC 60417

Type BF Class I

IEC 60417

Fuse