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Manufacturer

Indicates the medical device manufacturer.

ISO 15223-1 Medical devices – Symbols to be used with information to be supplied by the manufacturer.

Ref 5.1.1

Date of Manufacture

Indicates the date when the medical device was manufactured.

ISO 15223-1 Medical devices – Symbols to be used with information to be supplied by the manufacturer.

Ref 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 information to be supplied by the manufacturer.

Ref 5.1.4

Batch Code

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

ISO 15223-1 Medical devices – Symbols to be used with information to be supplied by the manufacturer.

Ref 5.1.5

Catalogue Number

Indicates the manufacturer’s catalogue number so that the medical device can be identified.

ISO 15223-1 Medical devices – Symbols to be used with information to be supplied by the manufacturer.

Ref 5.1.6

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 information to be supplied by the manufacturer.

Ref 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 information to be supplied by the manufacturer.

Ref 5.2.4

Single sterile barrier system

Indicates a single sterile barrier system.

ISO 15223-1 Medical devices – Symbols to be used with information to be supplied by the manufacturer.

Ref 5.2.11

Do Not Resterilize

Indicates a medical device that is not to be resterilized.

ISO 15223-1 Medical devices – Symbols to be used with information to be supplied by the manufacturer.

Ref 5.2.6

Do Not Use If Package Is Damaged and Consult Instructions For Use

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.

ISO 15223-1 Medical devices – Symbols to be used with information to be supplied by the manufacturer.

Ref 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 information to be supplied by the manufacturer.

Ref 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 information to be supplied by the manufacturer.

Ref 5.3.4

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 information to be supplied by the manufacturer.

Ref 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 information to be supplied by the manufacturer.

Ref 5.3.7

Do Not Re-Use

Indicates a medical device that is intended for one single use only.

ISO 15223-1 Medical devices – Symbols to be used with information to be supplied by the manufacturer.

Ref 5.4.2

Consult instructions for use or consult electronic 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 information to be supplied by the manufacturer.

Ref 5.4.3

Medical Device

Indicates the item is a medical device.

ISO 15223-1 Medical devices – Symbols to be used with information to be supplied by the manufacturer.

Ref 5.7.7

Unique Device Identifier

Indicates a carrier that contains unique device identifier information.

ISO 15223-1 Medical devices – Symbols to be used with information to be supplied by the manufacturer.

Ref 5.7.10

MR Safe

An item that poses no known health hazards resulting from exposure to any MR environment. MR Safe items are composed of materials that are electrically nonconductive, nonmetallic, and nonmagnetic.

ASTM F2503-20 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.

Ref 3.1.13, 7.4.4

MR Conditional

An item with demonstrated safety in the MR environment within defined conditions including conditions for the static magnetic field, the timevarying gradient magnetic fields and the radiofrequency fields.

ASTM F2503-20 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.

Ref 3.1.11, 7.4.6

MR Unsafe

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

ASTM F2503-20 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.

Ref 3.1.14, 7.4.10

Prescription Only

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

21 CFR.

Ref 801.109 (b)(1)