Medical device licence · 104362 · Class 3
ORISE GEL
No longer licensed: cancelled
Licence status Cancelled; first licensed March 5, 2020; ended July 6, 2023. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 104362
- Licence holder
- Boston Scientific CorporationWatertown, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group Family
- First licensed
- March 5, 2020
- Ended
- July 6, 2023
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OREL GEL SINGLE SYRINGE KIT WITH INTERJECT
- ORISE GEL
- ORISE GEL SINGLE SYRINGE KIT WITH INTERJECT
- ORISE GEL SYRINGE SINGLE PACK
- ORISE GEL SYRINGE TWIN PACK
- ORISE GEL TWIN SYRINGE KIT WITH INTERJECT
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.