Medical device licence · 60278 · Class 3
ISOSLEEVE DELIVERY SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed August 21, 2002; ended September 25, 2003. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 60278
- Licence holder
- Imagyn MedicalDenton, TX, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 21, 2002
- Ended
- September 25, 2003
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ISOSLEEVE DELIVERY SYSTEM - INTERSTITIAL SEED
- ISOSLEEVE DELIVERY SYSTEM - PRE-LOADED NEEDLE DELIVERY SYSTEM
- ISOSLEEVE DELIVERY SYSTEM - PROSTATE SEEDING NEEDLE/ISOSLEEVE ASSEMBLY
- ISOSLEEVE DELIVERY SYSTEM - SPACERS AND CALIBRATION SEED
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.