Medical device licence · 60505 · Class 3
STAPES PROSTHESES - TEFLON
Yes: licensed in Canada
Licence status Issued (active); first licensed August 24, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 60505
- Licence holder
- Gyrus Acmi, IncWestborough, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- August 24, 1999
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CAWTHORNE PISTONS
- FLUOROPLASTIC PISTONS
- SHEA CUP PISTONS/TEFLON
- SHEA LARGE-HEAD MALLEUS ATTACHMENT
- SHEA MALLEUS TEFLON PISTONS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.