Medical device licence · 470 · Class 4
CUSA EXCEL/CUSA EXCEL+ SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 18, 1998. It is in Health Canada’s list of active licences.
- Licence number
- 470
- Licence holder
- Integra Lifesciences (Ireland) LimitedTullamore, OF, Ireland
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- December 18, 1998
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CUSA EXCEL+ SYSTEM - CONSOLE
- CUSA EXCEL+ SYSTEM - CONTAMINATION GUARD
- CUSA EXCEL+ SYSTEM - CUSA EXCEL CONSOLES (LOANERS)
- CUSA EXCEL+ SYSTEM - HANDPIECE
- CUSA EXCEL+ SYSTEM - LAPARASCOPIC TIP AND FLUE PAK
- CUSA EXCEL+ SYSTEM - MACRO TIP AND FLUE PAK
- CUSA EXCEL+ SYSTEM - MANIFOLD TUBING SET
- CUSA EXCEL+ SYSTEM - MICRO TIP AND FLUE PAK
- CUSA EXCEL+ SYSTEM - NOSECONE AND SWITCHCOVERS
- CUSA EXCEL+ SYSTEM - PRECISION TIP AND FLUE PAK
- CUSA EXCEL+ SYSTEM - STANDARD TIP AND FLUE PAK
- FOOTSWITCH
- REUSABLE NOSECONE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.