Arthrex AR-6529S, Instructions For Use Manual

Page: 8 / 174

INSTRUCTIONS FOR USE
Document Number: D-720763
Page 8
Issue Date: 31 MAR 2020
Version: C Ref Blank Template: 80025118 Ver. E
1.4.4 Safe disposal:
Customers should adhere to all federal, state, regional, and/or local laws and
regulations as it pertains to the safe disposal of medical devices and accessories.
If in doubt, the users of the device shall first contact their supplier for guidance on
safe disposal protocols.
1.5 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