Medical device licence · 65189 · Class 3
VISTAFIX
Yes: licensed in Canada
Licence status Issued (active); first licensed July 14, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 65189
- Licence holder
- Cochlear Bone Anchored Solutions AbMolnlycke, Sweden
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 14, 2004
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CLIP ATTACHMENT 02MM
- COCHLEAR VISTAFIX VXA300 ABUTMENT
- COCHLEAR VISTAFIX VXA300 HEALING ABUTMENT
- COCHLEAR VISTAFIX VXI300 IMPLANT
- CONNECTION TO HANDPIECE
- COVER SCREWS
- DRILL COUNTERSINK
- FIXTURE ST
- GOLD BAR
- GOLD SCREW UNIGRIP FOR GOLD CYLINDER
- IMPLANT INSERTER
- MACHINE SCREWDRIVER ABUTMENT
- MACHINE SCREWDRIVER UNIGRIP
- SCREWDRIVER FOR INTERNAL HEXAGON
- SCREWDRIVER UNIGRIP
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.