Medical device licence · 70233 · Class 3
POROUS POLYETHYLENE SHEET IMPLANTS
Yes: licensed in Canada
Licence status Issued (active); first licensed January 17, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 70233
- Licence holder
- Synthes GmbhOberdorf, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- January 17, 2006
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- POROOUS/SMOOTH POLYETHYLENE SHEET, STERILE
- POROUS POLYETHELYENE ORBITAL FLOOR PLATE STERILE
- POROUS POLYETHEYLENE SMALL FAN PLATE STERILE
- POROUS POLYETHYLENE ORBITAL FLOOR PLATE
- POROUS POLYETHYLENE SHEET
- POROUS POLYETHYLENE SHEET, STERILE
- POROUS POLYETHYLENE SMALL FAN PLATE
- POROUS/SMOOTH POLYETHYLENE SHEET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.