Medical device licence · 106540 · Class 2
OSCAR PRO
Yes: licensed in Canada
Licence status Issued (active); first licensed August 14, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106540
- Licence holder
- Orthofix SrlVerona, Italy
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- August 14, 2021
- Devices covered
- 19
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OSCAR PRO FOOTSWITCH FOR IRRIGATION
- OSCAR PRO FOOTSWITCH FOR ULTRASOUND
- OSCAR PRO GENERATOR
- OSCAR PRO HANDSET HOLDER
- OSCAR PRO SLAP HAMMER
- OSCAR PRO TITANIUM CEMENT HOE STERILE
- OSCAR PRO TITANIUM CEMENT PIERCER STERILE
- OSCAR PRO TITANIUM CEMENT PLUG EXTRACTOR STERILE
- OSCAR PRO TITANIUM CEMENT SCRAPER STERILE
- OSCAR PRO TITANIUM CURVED BLADE SERRATED STERILE
- OSCAR PRO TITANIUM CURVED BLADE SMOOTH STERILE
- OSCAR PRO TITANIUM CURVED CEMENT PIERCER STERILE
- OSCAR PRO TITANIUM FLAT BLADE SMOOTH STERILE
- OSCAR PRO TITANIUM FLAT CEMENT PIERCER STERILE
- OSCAR PRO TITANIUM OSTEOTOME WEDGE TIP STERILE
- OSCAR PRO UNIVERSAL HANDSET
- OSCAR PRO UNIVERSAL HANDSET CABLE
- OSCAR PRO UNIVERSAL HANDSET HANDLE
- SPANNER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.