Medical device licence · 101218 · Class 2
ORISE TISSUE RETRACTOR SYSTEM
No longer licensed: cancelled
Licence status Cancelled; first licensed June 13, 2018; ended December 7, 2023. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 101218
- Licence holder
- Boston Scientific CorporationWatertown, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 13, 2018
- Ended
- December 7, 2023
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ORISE INSTRUMENT GUIDE
- ORISE TISSUE RETRACTOR
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “orise”. A notice may cover another product or only some lots: read it to see what it covers.
- Orise Gel Pack and Procedure KitDecember 30, 2022 · Ear, nose and throat - General and plastic surgery - General hospital and personal use · Performance · Type II
- Orise Proknife Procedure and Gel Syringe KitsOctober 26, 2022 · General and plastic surgery - General hospital and personal use · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.