Medical device licence · 89537 · Class 3
GLOBAL UNITE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 23, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 89537
- Licence holder
- Depuy Ireland UcRingaskiddy, CK, Ireland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 23, 2012
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GLOBAL UNITE ANATOMIC HEAD GUAGE
- GLOBAL UNITE CUTTING GUIDE
- GLOBAL UNITE EPI REAMER GUIDE
- GLOBAL UNITE IMPACTION SLIDE
- GLOBAL UNITE REVERSE FX EPI
- GLOBAL UNITE SYSTEM - ANATOMIC PROXIMAL BODY
- GLOBAL UNITE SYSTEM - COLLAR
- GLOBAL UNITE SYSTEM - EPIPHYSIS BODY
- GLOBAL UNITE SYSTEM - HUMERAL HEAD
- GLOBAL UNITE SYSTEM - STEM
- GLOBAL UNITE SYSTEM - TRIAL ANATOMIC PROXIMAL BODY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.