70
Quantity
Aantal geleverde instrumenten
Nombre de dispositifs inclus
Anzahl enthaltener Instrumente
Numero di dispositivi inclusi
Número de dispositivos incluídos
Número de dispositivos incluidos
Additional Symbols Used on Labeling
Symbol Description Standard
Prescription use only 21 CFR 801.109
Authorized Representative in the
European Community
ISO 15223-1:2016, Reference
5.1.2
Caution ISO 15223-1:2016, Reference
5.4.4
CE Mark with notified body reference
number
MDR Regulation (EU)
2017/745
www.hologic.com/package-inserts
Consult electronic instructions for
use
ISO 15223-1:2016, Reference
5.4.3
Translations in Box
Translations in Box Hologic
Do not use if package is damaged ISO 15223-1:2016, Reference
5.2.8
Catalog number ISO 15223-1:2016, Reference
5.1.6
Batch code ISO 15223-1:2016, Reference
5.1.5