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Les langues disponibles
Symbol and
Standard*
Reference No.
5.4.4
5.4.3
* Source: ISO 15223-1:2012-07-01, Medical devices — Symbols to be used with
medical device labels, labelling and information to be supplied — Part 1: General
requirements
**81 FR 38911 Use of Symbols in Labeling. Final Rule
Manufacturer:
Corporate Headquarters
OraMetrix, Inc.
2350 Campbell Creek Blvd.
Suite 400
Richardson, Texas 75082 USA
Phone +1 972 728 5500
DOC-500544
©2018 Dentsply Sirona
EN-06
OC-500544_Doctor_DFU_ALL_r13_4x7.25.indd 6
Title of
Symbol
Caution
Consult
Instructions for
Use
Prescription Use
**
Symbol Glossary
Description of Symbol
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
Indicates the need for the user to consult
the instructions for use.
Caution - US Federal law restricts this
device to sale by or on an order of a
dentist.
EC
Authorized EU Representative
OraMetrix GmbH
Rungestr. 19
10179 Berlin Germany
Phone +49 30 2430 910
Australian Sponsor
OraMetrix Pty. Limited
Suite 9, Level 6
10 Help Street
Chatswood NSW 2067 Australia
Phone +61 2 8035 5400
REP
10/10/18 9:02 A
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