Medical device licence · 89885 · Class 2
INDIGO HIGH-SPEED OTOLOGIC DRILL
Yes: licensed in Canada
Licence status Issued (active); first licensed October 16, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 89885
- Licence holder
- Medtronic Xomed Inc.Jacksonville, FL, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 16, 2012
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- INDIGO HIGH-SPEED OTOLOGIC DRILL
- INDIGO OTOLOGIC ANGLED ATTACHMENT
- INDIGO OTOLOGIC STRAIGHT ATTACHMENT
- INDIGO RND FINE DIAMOND BUR
- INDIGO RND SST CUTTING BUR
- INDIGO RND STEEL CUTTING BUR
- INDIGO TUBING
- SOFTWARE IPC UPGRADE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.