Additional Symbols Used on Labeling
Symbol
Translations in Box
www.hologic.com/package-inserts
Made in USA
Description
Prescription use only
Authorized Representative in the
European Community
CE Mark with notified body
reference number
Translations in Box
Consult electronic instructions
for use
Do not use if package is damaged
Catalog number
Batch code
Quantity
Manufacturer
Made in USA
Patents
Made in Costa Rica
Do not re sterilize
46
Standard
21 CFR 801.109
ISO 15223-1:2016,
Reference 5.1.2
MDR Regulation (EU)
2017/745
Hologic
ISO 15223-1:2016,
Reference 5.4.3
ISO 15223-1:2016,
Reference 5.2.8
ISO 15223-1:2016,
Reference 5.1.6
ISO 15223-1:2016,
Reference 5.1.5
Hologic
ISO 15223-1:2016,
Reference 5.1.1
Hologic
Hologic
Hologic
ISO 15223-1:2016,
Reference 5.2.6