Medical device licence · 110075 · Class 2
SURGI-MAX DRILL
Yes: licensed in Canada
Licence status Issued (active); first licensed September 22, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 110075
- Licence holder
- Elliquence, LlcBaldwin, NY, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- September 22, 2023
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ANGLED HANDPIECE
- ELECTRONIC MOTOR
- SINGLE-USE, STERILE DIAMOND SPINAL BURR
- SINGLE-USE, STERILE OVAL CYLINDRICAL BURR
- SINGLE-USE, STERILE OVAL EGG BURR
- SINGLE-USE, STERILE SUPPORT TUBE WITHOUT PROTECTOR
- SINGLE-USE, STERILE TUNGSTEN CARBIDE BURR
- STERILE SINGLE -USE, SUPPORT TUBE WITH BEVELED PROTECTION
- STERILE SINGLE-USE, SUPPORT TUBE WITH DISTAL PROTECTION
- SURGI-MAX DRILL CONSOLE
- SURGI-MAX DRILL FOOT PEDAL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.