US
Instructions for use
Symbols Glossary
Symbol
Description
Conssult the electronic instructions for use (eIFU) at
Caution
Non-sterile
Use-by date
Catalogue number
Batch code
Authorized representative in the European Community / European Union
Medical device
Manufacturer
Date of manufacture
MR Conditional
MR Conditional
Do not use if package is damaged and consult instructions for use / do not use if the
product sterile barrier system or its packaging is compromised
Rx Only
Caution: U.S. federal law restricts this device to sale by or on the order of a physician.
The reticle is a registered trademark of Acumed. It may appear alone or with the Acumed name.
CE marking of conformity, Article 17 of EU Directive 93/42/EEC or Article 20 of Regulation (EU) 2017/745. CE
marking may be accompanied by the identification number of the notified body responsible for conformity
assessment.
U.S. English – US / PAGE 10
www.acumed.net/ifu
ISO 15223-1
5.4.3
5.4.4
5.2.7
5.1.4
5.1.6
5.1.5
5.1.2
5.7.7
5.1.1
5.1.3
ASTM F2503-20
5.2.8
U.S. 21 CFR
801.109