Product Labeling Symbols
Symbol | Code | Standard | Ref # | Title | GS1 Application Identifier | Definition |
---|---|---|---|---|---|---|
| 3082 | 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. |