AngioDynamics C3 WAVE SYSTEM Gebrauchsanweisung Seite 11

In compliance with the requirements of 21 CFR Part 801.15, below is a glossary of symbols which appear
without accompanying text within the labeling of the C3 Wave System Accessories.
REF
SYMBOL TITLE OF SYMBOL
NUM
NA
RX Only
ONLY
5.1.1
Manufacturer
Authorized
5.1.2
representative
EC REP
in the European
Community
5.3.4
Keep Dry
5.3.6
Upper Limit of
00 ºC
Tempurature
5.3.2
Keep Away from
Sunlight
5.4.4
Caution
5.1.4
Use by
5.2.6
Do Not Resterilize
5.4.2
Do Not Reuse
5.2.7
Non-Sterile
5.2.3
Sterilized Using
Ethylene Oxide
Do Not Use
5.2.8
if Package is
Damaged
5.4.3
Consult
Instructions for Use
5.1.3 Date of
Manufacture
5.1.5
Batch Code
5.1.6
Catalogue Number
Universal Product
NA
Number
NA
Contents
5.1.8
Importer
5.7.7
MD
Medical Device
5.7.10
Unique Device
UDI
Identifier
a. 21 CFR 801.109 - Code of Federal Regulations.
b. ISO 15223-1: - Medical Devices – Symbols to be used with medical device labels, labeling and information to
be supplied.
MEANING OF SYMBOL
Caution: (US) Federal law restricts this device to sale by or on the order of
a licensed practitioner .
a
Indicates the medical device manufacturer.
Indicates the authorized representative in the European Community.
Indicates a medical device that needs to be protected from moisture
Indicates the temperature limits to which the medical device can be safely
exposed. b
Indicates a medical device that needs protection from light sources.
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 date after which the medical device is not to be used.
Indicates a medical device that is not to be resterilized.
Indicates a medical device that is intended for one use, or for use on a
single patient during a single procedure.
Indicates a medical device that has not been subjected to a sterilization
process. b
Indicates the medical device has been sterilized using ethylene oxide.
Indicates a medical device that should not be used if the package has
been damaged or opened. b
Indicates the need for the user to consult the instruction for use.
Indicates the date when the medical device was manufactured
Indicates the manufacturer's batch code so that the batch or lot can be
identified. b
Indicates the manufacturer's catalog number so that the medical device
can be identified. b
(UPN) code represents the manufacturer's number for an item
To indicate that the adjacent number reflects the number of units contained
in the package.
Indicates the entity importing the medical device into the locale.
Indicates the item is a medical device.
Indicates a carrier that contains unique device identifier information.
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b
. b
b
b
b
b
b
. b
b
b
b
b
b