Symbols Glossary

Compliance to global labeling regulations is a paramount priority. Our labeling follows global regulations including the Federal Drug Administration’s (FDA) General Device Labeling 21 CFR Part 801 and EU Medical Device Regulations (MDR) Article 23.1, Chapter III of Annexure I.

We use the following graphics, as required, to label our Medical Devices. These symbols are part of the ISO 15223-1:2021, EN 15986:2011, WEEE Directive 2012/19/EC, IEC 60601-1:2012 or MDR 2017/745 denoting the symbols and information to be provided on the labels of medical devices.

Authorized representative in the European Community

ISO 15223-1:2021

Batch code

ISO 15223-1:2021

Catalogue number

ISO 15223-1:2021

Caution

ISO 15223-1:2021

CE Mark

MDR 2017/745

CE 0123 Mark

MDR 2017/745

Contains or presence of bis (2-ethylhexyl) phthalate (DEHP)

EN 15986:2011

Country of manufacture

ISO 15223-1:2021

Contains or presence of phthalate

EN 15986:2011

Contains or presence of natural rubber latex

ISO 15223-1:2021

Consult instructions for use

ISO 15223-1:2021

Date of manufacture

ISO 15223-1:2021

Date of manufacture

ISO 15223-1:2021

Distributor

ISO 15223-1:2021

Do not resterilize

ISO 15223-1:2021

Do not re-use

ISO 15223-1:2021

Do not use if package is damaged

ISO 15223-1:2021

Follow instructions for use

IEC 60601-1:2012

Importer

ISO 15223-1:2021

Keep away from sunlight

ISO 15223-1:2021

Keep dry

ISO 15223-1:2021

Medical Device

ISO 15223-1:2021

Model number

ISO 15223-1:2021

Not made with phthalate

Not made with natural rubber latex

Not made with bis (2-ethylhexyl) phthalate (DEHP)

Non-sterile

ISO 15223-1:2021

Quantity

Separate collection for EEE

WEEE Directive 2012/19/EC

Single sterile barrier system with protective packaging outside

ISO 15223-1:2021

Single sterile barrier system with protective packaging inside

ISO 15223-1:2021

Single sterile barrier system

ISO 15223-1:2021

Sterilized using irradiation

ISO 15223-1:2021

Sterilized using ethylene oxide

ISO 15223-1:2021

Type BF applied part

IEC 60601-1:2012

Unique Device Identifier

ISO 15223-1:2021

Use-by date

ISO 15223-1:2021