Integra Cadence Total Ankle System Manual page 8

Title of
Symbol
Symbol
Indicates the date
Use-by date
after which the
(YYYY-MM-
medical device is
DD)
not to be used.
Indicates the
Consult need for the
instructions user to consult
for use the instructions
for use.
Indicates a
medical device
that is intended
Do not re-use for one use, or for
use on a single
patient during a
single procedure.
Indicates a
Sterilized
medical device
using
that has been
ethylene
sterilized using
oxide
ethylene oxide.
To indicate
the number
Quantity
of devices per
package.
6
Meaning of
Standard
Symbol
ISO 15223-1
Medical
Devices –
Symbols
to be
used with
medical
device
labels,
labelling
and
information
to be
supplied
Proprietary
Refer-
Title of
ence Symbol
Symbol
Number
5.1.4
Prescription
Use Only
5.4.3
5.4.2
Titanium
alloy
Cobalt
chromium
alloy
5.2.3
Ultra high
molecular
N/A
weight
polyethylene
CE Mark
0086
Meaning of
Standard
Symbol
Guidance
Caution: Federal for Industry:
(US) law restricts Alternative
this device to sale to Certain
by or on the order Prescription
of a physician Device
or licensed Labeling
healthcare Requirements,
practitioner. dated January
21, 2000
To indicate the
material of the
N/A
device is titanium
alloy.
To indicate the
material of the
N/A
device is cobalt
chromium alloy.
To indicate
the material
of the device
N/A
is ultra high
molecular weight
polyethylene.
Product complies
with the
93/42/EEC
requirements of
directive 93/42/EEC
Refer-
ence
Number
N/A
N/A
N/A
N/A
N/A