Medical device licence · 66025 · Class 3
SYNTHES EXTERNAL MIDFACE DISTRACTOR
Yes: licensed in Canada
Licence status Issued (active); first licensed October 4, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 66025
- Licence holder
- Synthes GmbhOberdorf, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 4, 2004
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EXTERNAL MID FACE DISTRACTOR SYSTEM - WIRE FIXATION SCREWS
- EXTERNAL MID FACE DISTRACTOR SYSTEM - HALO
- EXTERNAL MID FACE DISTRACTOR SYSTEM - HORIZONTAL BAR ASSY
- EXTERNAL MID FACE DISTRACTOR SYSTEM - MAXILLARY FOOTPLATE ASSY
- EXTERNAL MID FACE DISTRACTOR SYSTEM - NON-ARTICULATING VERTICAL ROD
- EXTERNAL MID FACE DISTRACTOR SYSTEM - PINS
- EXTERNAL MID FACE DISTRACTOR SYSTEM - ZYGOMATIC FOOTPLATE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.