Medical device licence · 8118 · Class 2
MOTORIZED HANDPIECES
Yes: licensed in Canada
Licence status Issued (active); first licensed July 15, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 8118
- Licence holder
- Karl Storz Se & Co. KgTuttlingen, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- July 15, 1999
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CRANIOTOME HANDPIECE
- DRILLCUT-X II N SHAVER HANDPIECE
- DRILLCUT-X II SHAVER HANDPIECE
- DRILLCUT-X II-35 N SHAVER HANDPIECE
- DRILLCUT-X II-35 SHAVER HANDPIECE
- HANDLE FOR DRILLCUT-X II SHAVER HANDPIECES
- HI PERFORMANCE ELECTRONIC MOTOR FOR USE WITH KS UNIDRIVE II
- INTRA-HANDPIECE
- MICRO MOTOR
- PERFORATOR HANDPIECE
- POWER SUPPLY FOR UNIDRIVE CONTROL UNIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.