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Glossary

View the medical device symbol glossary. Click on each term to view further details

Attention: Symbols on this page are for reference only. Products shown on the EyeSpace Lenses website may not be available in all markets and not all the symbols listed are applicable to your device.

Manufacturer

Explanation

Indicates the medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC

Standard Title

Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirement

Standard Reference

ISO 15223-1:2016 Ref no: 5.1.1
FDA Recognition no: 5-117
ISO 7000 Ref no: 3082
FDA Recognition no 5-124
EN 980, Clause 5.12

Batch Code

Explanation

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

Standard Title

Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirement

Standard Reference

ISO 15223-1:2016 Ref no: 5.1.5
FDA Recognition no: 5-117
ISO 7000 Ref no: 2492
FDA Recognition no 5-124
EN 980, Clause 5.4

Use-by Date

Explanation

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

Standard Title

Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements

Standard Reference

ISO 15223-1:2016 Ref no: 5.1.4
FDA Recognition no: 5-117
ISO 7000 Ref no: 2607
FDA Recognition no 5-124
EN 980, Clause 5.3

Consult instructions before use

Explanation

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

Standard Title

Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements

Standard Reference

ISO 15223-1:2016 Ref no: 5.4.3
FDA Recognition no: 5-117
ISO 7000 Ref no: 1641
FDA Recognition no: 5-124
EN 980, Clause 5.18

QR Code

Explanation

Directs user to Patient Resources

Standard Title

Information technology — Automatic identification and data capture techniques — QR Code 2005 bar code symbology specification

Standard Reference

ISO/IEC 18004:2006

Recyclable

Explanation

Indicates the packaging is recyclable

Standard Title

Graphical symbols for use on equipment — Registered symbols

Standard Reference

Do not use if package information is damaged

Explanation

Indicates a medical device that should not be used if the package has been damaged or opened

Standard Title

Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements

Standard Reference

Prescription Only

Explanation

Caution: Federal law restricts this device to sale by or on the order of a contact lens prescriber

Standard Title

Labeling-Prescription devices. Indicates the product is a medical device as defined in 21 CFR 820.3(l) and contact lens prescriber as defined in 16 CFR 315.2

Standard Reference

21 CFR 801.109
21 CFR 801.15(c)(1)(i)F