Medical device licence · 96105 · Class 2
STEREOTACTIC SURGERY ACCESSORIES
Yes: licensed in Canada
Licence status Issued (active); first licensed November 18, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 96105
- Licence holder
- Integra Lifesciences CorporationCincinnati, OH, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 18, 2015
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CANNULA
- DEPTH STOP, PLASTIC
- DRILL ASSEMBLY
- DRILL W/SET STOP
- GUIDE BLOCK
- GUIDE TUBE
- METAL DEPTH STOP
- NBND REDUCING TUBE
- REDUCING BUSHING
- REDUCING TUBE
- RULER
- STYLET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.