Medical device licence · 400 · Class 3
POLYURETHANE URETERAL STENT SETS
Yes: licensed in Canada
Licence status Issued (active); first licensed December 1, 1998. It is in Health Canada’s list of active licences.
- Licence number
- 400
- Licence holder
- Cook, IncorporatedBloomington, IN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group Family
- First licensed
- December 1, 1998
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BANDER URETERAL DIVERSION STENT SET
- C-FLEX DOUBLE PIGTAIL STENT SET
- C-FLEX MULTI-LENGTH STENT SET
- LARGE DIAMETER DOUBLE PIGTAIL SOF-FLEX STENT SET
- SOF-FLEX DOUBLE PIGTAIL STENT SET
- SOF-FLEX MULTI-LENGTH STENT SET
- SOF-FLEX PEDIATRIC DOUBLE PIGTAIL STENT SET - URETERAL
- ULTRATHANE ENDOURETEROTOMY STENT SET - URETERAL
- UNIVERSA FIRM URETERAL STENT SET
- UNIVERSA SOFT URETERAL STENT SET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.