Product Labeling

Symbol Title Code Standard Ref # GS1 Application ID Definition
Symbol 1 Manufacturer 3082 ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.1.1 n/a Indicates the medical device manufacturer.
Symbol 2 Authorized European Representative n/a ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.1.2 n/a Indicates the Authorized representative in the European Community.
Symbol 3 Date of Manufacture 2497 ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.1.3 (11) Indicates the date when the medical device was manufactured.
Symbol 4 Use by date 2607 ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.1.4 (17) Indicates the date after which the medical device is not to be used.
Symbol 5 Batch Code 2492 ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.1.5 (10) Indicates the manufacturer’s batch code so that the batch or lot can be identified. NOTE: Synonyms for “batch code” is “lot number”.
Symbol 6 Catalogue number 2493 ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.1.6 n/a Indicates the manufacturer’s catalogue number or part number so that the medical device can be identified.
Symbol 7 Serial Number 2498 ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.1.7 (21) Indicates the manufacturer’s serial number so that a specific medical device can be identified.
Symbol 8 Country of Manufacture 6049 ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.1.11 n/a To identify the country of manufacture of products.
Symbol 9 Do not resterilize 2608 ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.2.6 n/a Indicates a medical device that is not to be resterilized.
Symbol 10 Non-Sterile 2609 ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.2.7 n/a Indicates a medical device that has not been subjected to a sterilization process.
Symbol 11 Do not use if package is damaged and consult instructions for use 2606 ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.2.8 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.
Symbol 12 Keep dry 0626 ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.3.4 n/a Indicates a medical device that needs to be protected from moisture.
Symbol 13 Biological risks 0659 ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.4.1 n/a Indicates that there are potential biological risks associated with the medical device.
Symbol 14 Do not re-use 1051 ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.4.2 n/a Indicates a medical device that is intended for one single use only.
Symbol 15 Consult instructions for use 1641 ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.4.3 n/a Indicates the need for the user to consult the instructions for use.
Symbol 16 Caution 0434A ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.4.4 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.
Symbol 17 Importer 3725 ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.1.8 n/a To indicate the entity importing the medical device into the locale.
Symbol 18 Distributor 3724 ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.1.9 n/a Distributor.
Symbol 19 Unique Device Identifier n/a ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.7.10 n/a Indicates a carrier that contains unique device identifier information.
Symbol 20 Translation 3728 ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.7.7 n/a To identify that the original medical device information has undergone a translation which supplements or replaces the original information.
Symbol 21 Repackaging 3727 ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied 5.7.9 n/a To identify that a modification to the original medical device packaging configuration has occurred.
Symbol 22 RX Only n/a 21 CFR 801.15 n/a n/a Caution: Federal (US) Law restricts this device to sale by or on the order of a physician.
Symbol 23 CE Mark EU MDR 2017/745 and Regulation (EC) 765/2008 5.7.9 5.7.9 CE Mark Signifies European Conformity.
Symbol 1

Manufacturer

Code:
3082
Standard:
ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied
Ref #:
5.1.1
GS1 Application ID:
n/a
Definition:
Indicates the medical device manufacturer.
Symbol 2

Authorized European Representative

Code:
n/a
Standard:
ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied
Ref #:
5.1.2
GS1 Application ID:
n/a
Definition:
Indicates the Authorized representative in the European Community.
Symbol 3

Date of Manufacture

Code:
2497
Standard:
ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied
Ref #:
5.1.3
GS1 Application ID:
(11)
Definition:
Indicates the date when the medical device was manufactured.
Symbol 4

Use by date

Code:
2607
Standard:
ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied
Ref #:
5.1.4
GS1 Application ID:
(17)
Definition:
Indicates the date after which the medical device is not to be used.
Symbol 5

Batch Code

Code:
2492
Standard:
ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied
Ref #:
5.1.5
GS1 Application ID:
(10)
Definition:
Indicates the manufacturer’s batch code so that the batch or lot can be identified. NOTE: Synonyms for “batch code” is “lot number”.
Symbol 6

Catalogue number

Code:
2493
Standard:
ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied
Ref #:
5.1.6
GS1 Application ID:
n/a
Definition:
Indicates the manufacturer’s catalogue number or part number so that the medical device can be identified.
Symbol 7

Serial Number

Code:
2498
Standard:
ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied
Ref #:
5.1.7
GS1 Application ID:
(21)
Definition:
Indicates the manufacturer’s serial number so that a specific medical device can be identified.
Symbol 8

Country of Manufacture

Code:
6049
Standard:
ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied
Ref #:
5.1.11
GS1 Application ID:
n/a
Definition:
To identify the country of manufacture of products.
Symbol 9

Do not resterilize

Code:
2608
Standard:
ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied
Ref #:
5.2.6
GS1 Application ID:
n/a
Definition:
Indicates a medical device that is not to be resterilized.
Symbol 10

Non-Sterile

Code:
2609
Standard:
ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied
Ref #:
5.2.7
GS1 Application ID:
n/a
Definition:
Indicates a medical device that has not been subjected to a sterilization process.
Symbol 11

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

Code:
2606
Standard:
ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied
Ref #:
5.2.8
GS1 Application ID:
n/a
Definition:
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 12

Keep dry

Code:
0626
Standard:
ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied
Ref #:
5.3.4
GS1 Application ID:
n/a
Definition:
Indicates a medical device that needs to be protected from moisture.
Symbol 13

Biological risks

Code:
0659
Standard:
ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied
Ref #:
5.4.1
GS1 Application ID:
n/a
Definition:
Indicates that there are potential biological risks associated with the medical device.
Symbol 14

Do not re-use

Code:
1051
Standard:
ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied
Ref #:
5.4.2
GS1 Application ID:
n/a
Definition:
Indicates a medical device that is intended for one single use only.
Symbol 15

Consult instructions for use

Code:
1641
Standard:
ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied
Ref #:
5.4.3
GS1 Application ID:
n/a
Definition:
Indicates the need for the user to consult the instructions for use.
Symbol 16

Caution

Code:
0434A
Standard:
ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied
Ref #:
5.4.4
GS1 Application ID:
n/a
Definition:
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.
Symbol 17

Importer

Code:
3725
Standard:
ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied
Ref #:
5.1.8
GS1 Application ID:
n/a
Definition:
To indicate the entity importing the medical device into the locale.
Symbol 18

Distributor

Code:
3724
Standard:
ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied
Ref #:
5.1.9
GS1 Application ID:
n/a
Definition:
Distributor.
Symbol 19

Unique Device Identifier

Code:
n/a
Standard:
ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied
Ref #:
5.7.10
GS1 Application ID:
n/a
Definition:
Indicates a carrier that contains unique device identifier information.
Symbol 20

Translation

Code:
3728
Standard:
ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied
Ref #:
5.7.7
GS1 Application ID:
n/a
Definition:
To identify that the original medical device information has undergone a translation which supplements or replaces the original information.
Symbol 21

Repackaging

Code:
3727
Standard:
ISO 15223-1 Medical Devices – Symbols To Be Used with Medical Device Labels, Labeling, and Information to be Supplied
Ref #:
5.7.9
GS1 Application ID:
n/a
Definition:
To identify that a modification to the original medical device packaging configuration has occurred.
Symbol 22

RX Only

Code:
n/a
Standard:
21 CFR 801.15
Ref #:
n/a
GS1 Application ID:
n/a
Definition:
Caution: Federal (US) Law restricts this device to sale by or on the order of a physician.
Symbol 23

CE Mark

Code:
EU MDR 2017/745 and Regulation (EC) 765/2008
Standard:
5.7.9
Ref #:
5.7.9
GS1 Application ID:
CE Mark
Definition:
Signifies European Conformity.