Medical device licence · 109064 · Class 3
ULTRABUTTON ADJUSTABLE FIXATION DEVICE
Yes: licensed in Canada
Licence status Issued (active); first licensed March 15, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109064
- Licence holder
- Smith & Nephew, Inc. EndoscopyAndover, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- March 15, 2023
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ULTRABUTTON BB ADJUSTABLE FIXATION DEVICE
- ULTRABUTTON QUAD ADJUSTABLE FIXATION DEVICE
- ULTRABUTTON TIB ADJUSTABLE FIXATION DEVICE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.