Medical device licence · 80086 · Class 2
BLADES AND BURRS
Yes: licensed in Canada
Licence status Issued (active); first licensed June 30, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 80086
- Licence holder
- Smith & Nephew, Inc. EndoscopyAndover, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- June 30, 2009
- Devices covered
- 38
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ABRADER
- ABRADER ELITE
- ABRADER POWERMINI
- ACROMIOBLASTER ELITE
- ACROMIONIZER
- ACROMIONIZER ELITE
- BONECUTTER BLADE PLATINUM SERIES
- CUTTER
- DYONICS FLYER BLADE, PLATINUM SERIES
- DYONICS HIGH VISIBILITY SHEATH FLAT TOP BURR
- DYONICS, HIGH VISIBILITY SHEATH BARREL BURR
- FULL RADIUS
- FULL RADIUS BLADE PLATINUM SERIES
- FULL RADIUS BONECUTTER
- FULL RADIUS ELITE
- FULL RADIUS POWERMINI
- FULL RADIUS, CURVED, CONCAVE
- HELICUT
- HIGH VISIBILITY SHEATH ABRADER BURR
- INCISOR
- INCISOR PLUS
- INCISOR PLUS BLADE PLATINUM SERIES
- INCISOR PLUS ELITE
- INCISOR PLUS ELITE CURVED
- NOTCHBLASTER
- NOTCHBLASTER ELITE
- ORBIT FULL RADIUS
- ORBIT INCISOR
- ORBIT INCISOR PLUS
- ORBIT SYNOVATOR
- POWERMINI BARREL ABRADER BURR
- RAZORCUT
- STONECUTTER ELITE
- SYNOVATOR
- SYNOVATOR BLADE PLATINUM SERIES
- SYNOVATOR BONECUTTER
- SYNOVATOR, CURVED, CONCAVE
- TURBOTRIMMER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.