Arthrex AR-1627-15, Instructions For Use Manual

Page: 8 / 387

INSTRUCTIONS FOR USE
Document Number: 80028278
Page 8
Issue Date: 30 MAR 2020
Version: B Ref Blank Template: 80025118 Ver. E
Operating the system:
1.5.1 Applicable Symbols:
Symbol used Description Reference
Indicates the device is a medical device MDR 2017/745
Indicates the medical device manufacturer EN ISO 15223-1
Indicates the manufacturer’s serial number. The
device serial number is encoded as
1YYWWSSSSSSS.
 YY indicates the year of manufacture. i.e.
118WWSSSSSSS where 18 represents the
year 2018.
 WW indicates the number of the
manufacturing week per a standard shop
calendar. (Leading zeros included.)
 SSSSSSS is a sequential unique number.
EN ISO 15223-1
Indicates the medical device Global Trade Item
Number 21 CFR 830
MDR 2017/745
Indicates the date when the medical device
was manufactured
EN ISO 15223-1
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
th
, 2019 would be
represented as 19094.
EN ISO 15223-1
Indicates the manufacturer’s catalogue number EN ISO 15223-1
Indicates the need for the user to consult the
instructions for use for important cautionary
information such as warnings and precautions
EN ISO 15223-1
Indicates the device do not contain natural
rubber or dry natural rubber latex
EN ISO 15223-1
Indicates the authorized representative in the
European Community
EN ISO 15223-1