Medical device licence · 60493 · Class 3
NEWGEN/UNIVERSAL MANDIBULAR SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 16, 2002. It is in Health Canada’s list of active licences.
- Licence number
- 60493
- Licence holder
- Stryker Leibinger Gmbh & Co. KgKalamazoo, MI, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 16, 2002
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- NEWGEN/UNIVERSAL MANDIBULAR SYSTEM - INSTRUMENTATION
- NEWGEN/UNIVERSAL MANDIBULAR SYSTEM - LAG SCREWS
- NEWGEN/UNIVERSAL MANDIBULAR SYSTEM - TWIST DRILLS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.