Product Labeling Symbols

ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied

5.1.1

Manufacturer

n/a

Indicates the medical device manufacturer.

n/a

ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied

5.1.2

Authorized European Representative

n/a

Indicates the Authorized representative in the European Community.

2497

ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied

5.1.3

Date of Manufacture

(11)

Indicates the date when the medical device was manufactured.

2607

ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied

5.1.4

Use by date

(17)

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

2492

ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied

5.1.5

Batch Code

(10)

Indicates the manufacturer’s batch code so that the batch or lot can be identified. NOTE: Synonyms for “batch code” is “lot number”.

2493

ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied

5.1.6

Catalogue number

n/a

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

2498

ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied

5.1.7

Serial Number

(21)

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

6049

ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied

5.1.11

Country of Manufacture

n/a

To identify the country of manufacture of products.

2608

ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied

5.2.6

Do not resterilize

n/a

Indicates a medical device that is not to be resterilized.

2609

ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied

5.2.7

Non-Sterile

n/a

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

2606

ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied

5.2.8

Do not use if package is damaged and consult instructions for use

n/a

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.

0626

ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied

5.3.4

Keep dry

n/a

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

0659

ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied

5.4.1

Biological risks

n/a

Indicates that there are potential biological risks associated with the medical device.

1051

ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied

5.4.2

Do not re-use

n/a

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

1641

ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied

5.4.3

Consult instructions for use

n/a

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

0434A

ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied

5.4.4

Caution

n/a

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.

3725

ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied

5.1.8

Importer

n/a

To indicate the entity importing the medical device into the locale.

3724

ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied

5.1.9

Distributor

n/a

Distributor

n/a

ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied

5.7.10

Unique Device Identifier

n/a

Indicates a carrier that contains unique device identifier information.

3728

ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied

5.7.7

Translation

n/a

To identify that the original medical device information has undergone a translation which supplements or replaces the original information.

3727

ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied

5.7.9

Repackaging

n/a

To identify that a modification to the original medical device packaging configuration has occurred.

n/a

21 CFR 801.15

n/a

RX Only

n/a

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

n/a

EU MDR 2017/745 and Regulation (EC) 765/2008

5.7.9

CE Mark

n/a

Signifies Euorpean Conformity.