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INSTRUCTIONS FOR USE
1.5.2 Intended User and Patient Population:
Intended User: Surgeons, Nurses, Doctors, Physicians and OR healthcare
professionals involved in the device intended procedure. Not intended for Lay
persons.
Document Number: 80028209
Version: A
Indicates the medical device Global
Trade Item Number
Indicates the date when the medical
device was manufactured
Indicates the manufacturer's lot code
using the Julian Date yyddd, where yy
indicates the last two digits of the year
and ddd indicates the day of the year.
i.e. April 4
, 2019 would be represented
th
as 19094.
Indicates the manufacturer's
catalogue number
Indicates the need for the user to
consult the instructions for use for
important cautionary information such
as warnings and precautions
Indicates the device do not contain
natural rubber or dry natural rubber
latex
Indicates the authorized representative
in the European Community
Indicates the Medical Device complies
to REGULATION (EU) 2017/745
Indicates a Warning
Intended to show when the IFU
should be referenced for use
Page 8
21 CFR 830
MDR 2017/745
EN ISO 15223-1
EN ISO 15223-1
EN ISO 15223-1
EN ISO 15223-1
EN ISO 15223-1
EN ISO 15223-1
MDR 2017/745
IEC 60601-1
EN ISO 15223-1
Issue Date: 23 MAR 2020
Ref Blank Template: 80025118 Ver. E
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