Use Instructions

PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 39 of 101
4.2. CSS – Custom Sterile Sleeve Device Label
The following label is applied to the Custom Sterile Sleeve.
4.2.1. Symbols on CSS Device Label
Table 11 Symbols on CSS Device Label
# Symbol Meaning Source
1.
Manufacturer Information ISO 7000 - 3082
2.
Indicating the device is to be used
by qualified investigators only, in
accordance with SBI-CIP-20-002
N/A
3.
Device Model Name N/A
4.
Reference Number ISO 7000 - 2493
5.
Lot Number ISO 7000 - 2492