Medical device licence · 90507 · Class 2
STONEBREAKER SYSTEM
No longer licensed: cancelled
Licence status Cancelled; first licensed January 14, 2013; ended May 17, 2019. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 90507
- Licence holder
- Cook, IncorporatedBloomington, IN, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Single Device
- First licensed
- January 14, 2013
- Ended
- May 17, 2019
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- STONEBREAKER SYSTEM - CO2 CARTRIDGE
- STONEBREAKER SYSTEM - PNEUMATIC LITHOTRIPTER
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “stonebreaker”. A notice may cover another product or only some lots: read it to see what it covers.
- LMA StoneBreaker Intracorporeal Lithotripter System and StoneBreaker System - Pneumatic Lithotripter (2018-03-13)May 1, 2018 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.