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8 – 148 × 210 mm – 44000231488/02 –
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– 20-095 kn
8
Reference
Number &
Symbol
Title
Symbol Description of Symbol
Corrosive
Product is classified as
corrosive. Source: Globally
Harmonized Symbols for
Classifying Hazardous
Chemicals
Rx Only
Indicates that U.S. Federal
Law restricts this device to
sale by or on the order of a
dental professional. 21 Code
of Federal Regulations
(
CFR
) sec. 801.109(b)(1).
Recycle
1
Indicates packaging is recy-
clable with mixed paper.
Low-density
polyethylene
Indicates plastic compo-
nent made of low-density
polyethylene is recyclable.
Official Journal of the
EC
;
Commission Decision
(97/129/
EC
)
Green Dot
Indicates a financial contri-
bution to national packag-
ing recovery company per
European Directive No.
94/62 and corresponding
national law. Packaging
Recovery Organization
Europe.
Information valid as of July 2020
Symbol Glossary
Reference
Number &
Symbol
Title
Symbol Description of Symbol
ISO
15223-1
5.1.1
Manufac-
turer
Indicates the medical
device manufacturer as
defined in
EU
Directives
90/385/
EEC
, 93/42/
EEC
and 98/79/
EC
.
ISO
15223-1
5.1.3
Date of
Manufacture
Indicates the date when
the medical device was
manufactured.
ISO
15223-1
5.1.4
Use-by date
Indicates the date after
which the medical device is
not to be used.
ISO
15223-1
5.1.5
Batch code
Indicates the manufac-
turer's batch code so that
the batch or lot can be
identified.
ISO
15223-1
5.1.6
Catalogue
number
Indicates the manufac-
turer's catalogue number so
that the medical device can
be identified.
ISO
15223-1
5.3.7
Temperature
limit
Indicates the temperature
limits to which the medi-
cal device can be safely
exposed.
ISO
15223-1
5.4.2
Do not
re-use
Indicates a medical device
that is intended for one use
or for use on a single patient
during a single procedure.
ISO
15223-1
5.4.4
Caution
Indicates the need for the
user to consult the instruc-
tions 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.
CE
Mark
Indicates conformity to
European Union Medi-
cal Device Regulation or
Directive with notified body
involvement.
Medical
Device
Indicates the item is a medi-
cal device.