Medical device licence · 13047 · Class 4
UNI-SHUNT SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 15, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 13047
- Licence holder
- Integra Lifesciences Production CorporationMansfield, MA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- October 15, 1999
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- UNI-SHUNT ABDOMINAL SLIP CLIP
- UNI-SHUNT ANCHORING CLIP
- UNI-SHUNT ANCHORING CLIP
- UNI-SHUNT CATHETER PASSER
- UNI-SHUNT ELLIPTICAL RESERVOIR KIT
- UNI-SHUNT SYSTEMS
- UNI-SHUNT WITH RESERVOIR
- UNI-SHUNT WITH RESERVOIR CATHETER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.