Medical device licence · 98227 · Class 2
DRAGONFLY SURGICAL DRILL SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 14, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 98227
- Licence holder
- Grace Medical, Inc.Memphis, TN, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- December 14, 2016
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DRAGONFLY BATTERIES AND SEAL KIT
- DRAGONFLY CHARGING SYSTEM
- DRAGONFLY CYLINDER CUTTING BUR WITH BURSHIELD
- DRAGONFLY EGG CUTTING BUR WITH BURSHIELD
- DRAGONFLY ROUND CUTTING BUR WITH BURSHIELD
- DRAGONFLY ROUND DIAMOND "SKINNY", BUR
- DRAGONFLY ROUND DIAMOND BUR
- DRAGONFLY ROUND DIAMOND BUR WITH BURSHIELD
- DRAGONFLY STERILIZATION TRAY
- DRAGONFLY SURGICAL DRILL SYSTEM POWERED BY INVISIDRIVE
- DRAGONFLY SURGICAL DRILL SYSTEM, POWERED BY INVISIDRIVE FOOTSWITCH
- DRAGONFLY TROCAR PERFORATOR BUR
- DRAGONFLY, POWERED BY INVISIDRIVE ANGLED ADAPTOR
- DRAGONFLY, POWERED BY INVISIDRIVE HANDPIECE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.