Medical device licence · 6804 · Class 2
OMEGA BURS (CARBIDE)
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed June 29, 1999; ended November 7, 2003. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 6804
- Licence holder
- Omega Surgical Instruments,IncGrand Blanc, MI, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- June 29, 1999
- Ended
- November 7, 2003
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OMEGA ULTRALITE SINGLE USE BURS - SIDE CUTTIN AND ROUND CUTTING
- OMEGA ZIMMER REPLAC. BURS, LONG CARBIDE - SIDE CUTTING,ROUND,OVAL & BARREL
- OMEGA ZIMMER REPLAC.BUR, MEDIUM CARBIDE (SIDE,ROUND,OVAL & BARREL CUTTING)
- OMEGA ZIMMER REPLACEMENT BURS, EXTRA-LONG CARBIDE (ROUND & OVAL CUTTING)
- OMEGA ZIMMER REPLACEMENT BURS, SHORT CARBIDE (SIDE AND ROUND CUTTING)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.