Medical device licence · 81144 · Class 2
MICROTARGETING STAR DRIVE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 5, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 81144
- Licence holder
- Fhc, Inc.Bowdoin, ME, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 5, 2009
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DEPTH STOP ADAPTER
- MICROTARGETING STAR DRIVE SYSTEM
- MICROTARGETING STAR DRIVE SYSTEM - ACCESSORIES
- MICROTARGETING STAR DRIVE SYSTEM - ARRAY INSERTION TUBES
- MICROTARGETING STAR DRIVE SYSTEM - FRAME ADAPTERS
- MICROTARGETING STAR DRIVE SYSTEM - STAR DRIVE ONLY
- MICROTARGETING STAR DRIVE SYSTEM - WASH & STERILIZATION CASE
- MICROTARGETTING LEAD INSERTION TUBE SET
- STAR INSERTER KIT
- STARDRIVE ADAPTER
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 “microtargeting”. A notice may cover another product or only some lots: read it to see what it covers.
- microTargeting Drive System, STar Drive System (2018-04-29)May 31, 2019 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.