Medical device licence · 88060 · Class 2
IO-FLEX SYSTEM
No longer licensed: suspended: invalid quality-system certificate
Licence status Suspended: invalid quality-system certificate; first licensed January 13, 2012; ended April 15, 2015. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 88060
- Licence holder
- Baxano Surgical Inc.Raleigh, NC, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- January 13, 2012
- Ended
- April 15, 2015
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- IO-FLEX CONTRA IRRIGATION CANNULA
- IO-FLEX CONTRA PROBE
- IO-FLEX CONTRA PROBE PLUS IRRIGATION CANNULA
- IO-FLEX DISTAL HANDLE
- IO-FLEX IPSI IRRIGATION CANNULA
- IO-FLEX IPSI PROBE
- IO-FLEX IPSI PROBE PLUS IRRIGATION CANNULA
- IO-FLEX IPSI PROBE S
- IO-FLEX MICROBLADE SHAVER
- IO-FLEX MICROBLADE SHAVER WITH SIDE CUTTER
- IO-FLEX NEURO CHECK WITH WIRE
- IO-FLEX SYSTEM-IO-TOME
- IO-FLEX WITH WIRE
- IO-N ADAPTER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.