Medical device licence · 91353 · Class 2
TRANSPALATAL DISTRACTOR SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 27, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 91353
- Licence holder
- Synthes GmbhOberdorf, Switzerland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- May 27, 2013
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- TRANSPALATAL DISTRACTOR - ACTIVATION INSTRUMENT
- TRANSPALATAL DISTRACTOR - BLOCKING SCREW
- TRANSPALATAL DISTRACTOR - BODY
- TRANSPALATAL DISTRACTOR - FOOT PLATE
- TRANSPALATAL DISTRACTOR - PATIENT INSTRUMENT
- TRANSPALATAL DISTRACTOR - SIZER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.