Medical device licence · 98419 · Class 2
OSTEOTOMES (OSTEOSAFE)
Yes: licensed in Canada
Licence status Issued (active); first licensed January 19, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 98419
- Licence holder
- AnthogyrSallanches, France
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- January 19, 2017
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EXTENSION DE MANDRIN OSTEOTOME
- FULL OSTEOTOMY SET
- INSTRUMENT UNIVERSEL CHIRURGIE
- MANDRIN DE VISSAGE TRILOBE
- OSTEOTOME BAIONNET
- OSTEOTOME DROIT
- OSTEOTOME IMPLANT TL MANDREL
- SAFE IMPACTOR
- SET OSTEOTOME, BAIONNET
- SET OSTEOTOME, DROIT
- SET OSTEOTOMIE
- SET OSTEOTOMIE COMPLET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.