Medical device licence · 91302 · Class 2
KYPHOPLASTY PROCEDURE
No longer licensed: suspended: invalid quality-system certificate
Licence status Suspended: invalid quality-system certificate; first licensed October 28, 2013; ended July 9, 2015. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 91302
- Licence holder
- Gallini S.R.L.Mantova, MO, Italy
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 28, 2013
- Ended
- July 9, 2015
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- KYPHOPLASTY PROCEDURE ACCESS NEEDLE
- KYPHOPLASTY PROCEDURE CEMENT INJECTION CANULA
- KYPHOPLASTY PROCEDURE DILATOR CATHETER
- KYPHOPLASTY PROCEDURE DILATOR NEEDLE
- KYPHOPLASTY PROCEDURE DRILL
- KYPHOPLASTY PROCEDURE INFLATION DEVICE
- KYPHOPLASTY PROCEDURE KIRSCHNER WIRE
- KYPHOPLASTY PROCEDURE MIXER
- KYPHOPLASTY PROCEDURE SAVE SPINER
- KYPHOPLASTY PROCEDURE SYRINGE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.