Medical device licence · 95452 · Class 2
TRAUMA RECON SYSTEM (TRS)
Yes: licensed in Canada
Licence status Issued (active); first licensed July 17, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95452
- Licence holder
- Synthes GmbhOberdorf, Switzerland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 17, 2015
- Devices covered
- 22
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADAPTER FOR RADIOLUCENT DRIVE
- ANGULAR DRIVE UNIT FOR MEDULLARY REAMING
- AO/ASIF QUICK COUPLING
- ATTACHMENT FOR ACETABULAR AND MEDULLARY REAMING
- BATTERY HANDPIECE
- DRILL CHUCK
- DRILL CHUCK, KEYLESS
- HARRIS ADAPTER
- HUDSON QUICK COUPLING
- KUENTSCHER ADAPTER
- LID
- POWER MODULE
- QUICK COUPLING
- RADIOLUCENT DRIVE
- RECIPROCATING SAW ATTACHMENT
- SAGITTAL SAW ATTACHMENT
- SCREW ATTACHMENT
- STERILE COVER, FOR TRAUMA RECON SYSTEM
- TOP FOR STERNUM FOR RECIPROCATING SAW ATTACHMENT
- TORQUE LIMITER
- TRINKLE QUICK COUPLING
- UNIVERSAL BATTERY CHARGER II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.