Medical device licence · 104713 · Class 3
RAPIDSORB INJECTABLE POLYMER SYSTEM (IPS)
Yes: licensed in Canada
Licence status Issued (active); first licensed June 4, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104713
- Licence holder
- Synthes GmbhOberdorf, Switzerland
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 4, 2020
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DRILL BIT WITH STOP J-LATCH F/RAPIDSORB IPS-STER
- RAPIDSORB IPS BATTERY PACK STERILE
- RAPIDSORB IPS DELIVERY DEVICE STARTER KIT, STERILE
- RAPIDSORB IPS FASTENER CARTRIDGE STERILE
- RAPIDSORB IPS POWER DRIVE UNIT
- REPLACEMENT IPS DELIVERY DEVICE REPLACEMENT CAP-STERILE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.