Medical device licence · 103184 · Class 3
WAYPOINT STEREOTACTIC SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 10, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103184
- Licence holder
- Fhc, Inc.Bowdoin, ME, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 10, 2019
- Devices covered
- 43
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADTECH BOLT GUIDE
- BILATERAL PLATFORM
- BILATERAL SURGICAL KIT
- CUSTOMIZED PLATFORM PHANTOM
- DUAL DEPTH STOP HOLDER
- FIDUCIAL PLACEMENT TEMPLATE
- FOUR LEGGED UNILATERAL PLATFORM
- INSERTER KIT
- INSERTION TUBE DEPTH STOP
- INTEGRATED RING SCREW, PEEK THUMBKNOB
- MULTI OBLIQUE DUAL TRAJECTORY PLATFORM
- MULTI OBLIQUE EPILEPSY PLATFORM
- MULTI OBLIQUE SINGLE TRAJECTORY PLATFORM
- MULTI-OBLIQUE STERILIZATION AND STORAGE KIT
- MULTI-OBLIQUE DEPTH STOP
- NEUROBLATE PLATFORM ADAPTOR KIT
- PEEK STANDOFF
- PEEK THUMBKNOB
- PEEK THUMBKNOB WITH STANDOFF
- PLATFORM INDEXING RING SS THUMBKNOBS
- SS STANDOFF
- SS THUMBKNOB
- SS THUMBKNOB WITH STANDOFF
- STAGED BILATERAL PLATFORM
- THREE LEGGED UNILATERAL PLATFORM
- TOOL GUIDE FOR PLATFORM
- TOOL GUIDE
- VISUALASE ALIGNMENT ROD GUIDE
- WAYPOINT ANCHORS
- WAYPOINT COMBINATION DRIVER
- WAYPOINT COMBINATION DRIVER W/ COLLAR
- WAYPOINT HEX WRENCH
- WAYPOINT IMPLANT KIT
- WAYPOINT IMPLANTATION KIT, REUSABLE COMPONENTS
- WAYPOINT LOCATOR PINS
- WAYPOINT MANUAL DRIVER HANDLE
- WAYPOINT NAVIGATOR
- WAYPOINT PILOT DRILL BIT
- WAYPOINT PLANNER
- WAYPOINT PLATFORM SURGICAL KIT
- WAYPOINT STANDOFF WRENCH
- WAYPOINT STERILIZATION/STORAGE CASE
- WAYPOINT SURGICAL KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.