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SHALL CONFORM TO THE PRODUCT LIMITED WARRANTY AS PROVIDED IN THE PRODUCT LABELING OR
APPLICABLE PRODUCT CATALOG . THIS WARRANTY IS EXCLUSIVE, AND INTEGRA DISCLAIMS ALL OTHER
WARRANTIES, WHETHER EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE . INTEGRA SHALL NOT BE LIABLE
FOR ANY INCIDENTAL OR CONSEQUENTIAL LOSS, DAMAGE, OR EXPENSE, DIRECTLY OR INDIRECTLY ARISING
FROM USE OF THESE PRODUCTS . INTEGRA NEITHER ASSUMES NOR AUTHORIZES ANY PERSON TO ASSUME
ANY OTHER OR ADDITIONAL LIABILITY OR RESPONSIBILITY IN CONNECTION WITH THESE PRODUCTS .
Symbol
Title of Symbol
Manufacturer
Authorized
representative
in the European
Community
Date of
manufacture
(YYYY-MM-DD)
Batch code
Catalogue
Number
Nonsterile
Consult
instructions
for use
Caution
Prescription Use
Only
Quantity
Made In
Medical device
Meaning of Symbol
Indicates the medical device
manufacturer, as defined in EU
Directives 90/385/EEC, 93/42/EEC and
98/79/EC .
Indicates the authorized representative
in the European Community
Indicates the date when the medical
device was manufactured .
Indicates the manufacturer's batch
code so that the batch or lot can be
identified .
Indicates the manufacturer's catalogue
number so that the medical device can
be identified .
To indicate the device is
provided non-sterile
Indicates the need for the user to
consult the instructions for use .
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 .
Caution: Federal (US) law restricts
this device to sale by or on the order
of a physician or licensed healthcare
practitioner .
To indicate the number of devices per
package
N/A
Indicates the item is a medical device
8 8
Standard
ISO 15223-1 Medical Devices –
Symbols to be used with medical
device labels, labelling and
information to be supplied
ISO 15223-1 Medical Devices –
Symbols to be used with medical
device labels, labelling and
information to be supplied
ISO 15223-1 Medical Devices –
Symbols to be used with medical
device labels, labelling and
information to be supplied
ISO 15223-1 Medical Devices –
Symbols to be used with medical
device labels, labelling and
information to be supplied
ISO 15223-1 Medical Devices –
Symbols to be used with medical
device labels, labeling and
information to be supplied
Proprietary
ISO 15223-1 Medical Devices –
Symbols to be used with medical
device labels, labeling and
information to be supplied
ISO 15223-1 Medical Devices –
Symbols to be used with medical
device labels, labelling and
information to be supplied
Guidance for Industry: Alternative
to Certain Prescription Device
Labeling Requirements, dated
January 21, 2000
Proprietary
Proprietary
ISO 15223-1 Medical Devices –
Symbols to be used with medical
device labels, labelling and
information to be supplied
Reference
Number
5 . 1 . 1
5 . 1 .2
5 . 1 .3
5 . 1 .5
5 . 1 .6
N/A
5 .4 .3
5 .4 .4
N/A
N/A
N/A
5 . 7 . 7
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