Symbol Glossary

Explanation of Symbols

The following symbols may appear on the packaging, labelling or instructions for use of medical devices.

SymbolTitleDescriptionStandard / Reference
Manufacturer Manufacturer Indicates the medical device manufacturer ISO 15223-1, 5.1.1 (ISO 7000-3082)
Authorized Representative in the European Community/ European Union Authorized Representative in the European Community/ European Union Indicates the authorized representative in the European Community / European Union ISO 15223-1, 5.1.2
Authorized Representative in Switzerland Authorized Representative in Switzerland Indicates the authorized representative in Switzerland ISO 20417, 6.1.2 (d)
Importer Importer Indicates the entity importing the medical device into the locale ISO 15223-1, 5.1.8 (ISO 7000-3725)
Distributor Distributor Indicates the entity distributing the medical device into the locale ISO 15223-1, 5.1.9 (ISO 7000-3724)
Country of Manufacture Country of Manufacture To identify the country of manufacture of products ISO 15223-1, 5.1.11 (IEC 60417-6049)
Do Not Re-use 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”. ISO 15223-1, 5.4.2 (ISO 7000-1051)
Date of Manufacture Date of Manufacture Indicates the date when the medical device was manufactured ISO 15223-1, 5.1.3 (ISO 7000-2497)
Use-by Date Use-by Date Indicates the date after which the medical device is not to be used ISO 15223-1, 5.1.4 (ISO 7000-2607)
Batch Code Batch Code Indicates the manufacturer's batch code so that the batch or lot can be identified. NOTE: Synonyms for “batch code” are “lot number”, “lot code” and “batch number”. ISO 15223-1, 5.1.5 (ISO 7000-2492)
Unique Device Identifier Unique Device Identifier Indicates a carrier that contains unique device identifier information ISO 15223-1, 5.7.10
Medical Device Medical Device Indicates the item is a medical device ISO 15223-1, 5.7.7
Catalogue number Catalogue number Indicates the manufacturer's catalog number so that the medical device can be identified ISO 15223-1, 5.1.6 (ISO 7000-2493)
Model Number Model Number Indicates the model number or type number of a product ISO 15223-1, 5.1.10 (IEC 60417-6050)
Serial Number Serial Number Indicates the manufacturer's serial number so that a specific medical device can be identified ISO 15223-1, 5.1.7 (ISO 7000-2498)
Consult Instructions for Use or Consult Electronic Instructions for Use 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, A.16
Consult Instructions for Use or Consult Electronic Instructions for Use 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, 5.4.3 (ISO 7000-1641)
Contains or Presence of Natural Rubber Latex Contains or Presence of Natural Rubber Latex Indicates the presence of dry natural rubber or natural rubber latex as a material of construction within the medical device or the packaging of a medical device ISO 15223-1, 5.4.5 (ISO 7000, Symbol 2725)
Not Made with or Absence of Natural Rubber Latex Not Made with or Absence of Natural Rubber Latex Indicates the absence of dry natural rubber or natural rubber latex as a material of construction within the medical device or the packaging of a medical device ISO 15223-1, Annex B (b.2)
Do Not Use if Package is Damaged and Consult Instructions for Use 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, 5.2.8 (ISO 7000-2606)
Sterile Sterile Indicates a medical device that has been subjected to a sterilization process ISO 15223-1, 5.2.1 (ISO 7000-2499)
Sterilized Using Irradiation Sterilized Using Irradiation Indicates a medical device that has been sterilized using irradiation ISO 15223-1, 5.2.4 (ISO 7000-2502)
Non-Sterile Non-Sterile Indicates a medical device that has not been subjected to a sterilization process ISO 15223-1, 5.2.7 (ISO 7000-2609)
Single Sterile Barrier System with Protective Packaging Inside Single Sterile Barrier System with Protective Packaging Inside Indicates a single sterile barrier system with protective packaging inside ISO 15223-1, 5.2.13 (ISO 7000-3708)
Single Sterile Barrier System with Protective Packaging Outside Single Sterile Barrier System with Protective Packaging Outside Indicates a single sterile barrier system with protective packaging outside ISO 15223-1, 5.2.14 (ISO 7000-3709)
Keep Away from Sunlight Keep Away from Sunlight Indicates a medical device that needs protection from light sources ISO 15223-1, 5.3.2 (ISO 7000-0624)
Keep Dry Keep Dry Indicates a medical device that needs protection from moisture ISO 15223-1, 5.3.4 (ISO 7000-0626)
Temperature Limit Temperature Limit Indicates the temperature limits to which the medical device can be safely exposed ISO 15223-1, 5.3.7 (ISO 7000-0632)
CE Marking CE Marking CE marking of conformity means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing Regulation (EU) 2017/745, Annex V
UKCA Marking UKCA Marking UKCA marking of conformity means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements for products sold within Great Britain The Medical Devices Regulations 2002
Swiss MD Marking Swiss MD Marking Swiss MD marking of conformity means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements for products sold within Switzerland Medical Devices Ordinance (MedDO), Annex 5
Contains potential Type IV chemical allergens Contains potential Type IV chemical allergens For any medical glove where chemical ingredients such as accelerators, antioxidants and biocides are added during the manufacturing or already known to be present in the product and there is a residual risk of causing Type IV allergy BS EN 455-3, 4.6 (b)

Note: not all symbols necessarily appear on every product. The information on the respective product packaging and in the accompanying instructions for use always prevails.