Integra Cadence Total Ankle System Gebrauchsanweisung Seite 6

EN – ENGLISH
Symbol Title of Symbol Meaning of Symbol
Indicates a medical
device that is intended
for one use, or for use
Do not re-use
on a single patient
during a single
procedure.
Indicates a medical
Sterilized using device that has been
ethylene oxide sterilized using
ethylene oxide.
Date of Indicates the date when
manufacture the medical device was
(YYYY-MM-DD) manufactured.
To indicate the number
Quantity
of devices per package
Caution: Federal (US)
law restricts this device
Prescription Use to sale by or on the
Only order of a physician
or licensed healthcare
practitioner.
Product complies with
the requirements of
CE Mark
directive 93/42/EEC
2797
Indicates that the
product is classified
Medical Device as a medical device
per Regulation (EU)
2017/745
Reference
Standard
Number
5.4.2
ISO 15223-1
Medical Devices
– Symbols to be
used with medical
device labels,
5.2.3
labelling and
information to be
supplied
5.1.3
Proprietary N/A
Guidance
for Industry:
Alternative
to Certain
Prescription N/A
Device Labeling
Requirements,
dated January 21,
2000
93/42/EEC N/A
N/A N/A
5
Symbol Title of Symbol Meaning of Symbol
To indicate the material
Titanium alloy of the device is titanium
alloy.
To indicate the material
Cobalt chromium
of the device is cobalt
alloy
chromium alloy.
To indicate the material
Ultra high
of the device is ultra
molecular weight
high molecular weight
polyethylene
polyethylene.
To indicate the
Commercially material of the device
pure titanium is commercially pure
titanium.
Reference
Standard
Number
N/A N/A
N/A N/A
N/A N/A
N/A N/A