Medical device licence · 84004 · Class 3
PEEK TWINLOOP SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 29, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 84004
- Licence holder
- Stryker Endoscopy, A Div. Of Stryker Corp.San Jose, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 29, 2010
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PEEK TWINLOOP ANCHOR SUTURE EYELET (SE) W/ONE STRAND OF FORCE FIBER
- PEEK TWINLOOP ANCHOR SUTURE EYELET (SE) W/TWO STRAND OF FORCE FIBER
- PEEK TWINLOOP ANCHOR W/ONE STRAND OF FORCE FIBER
- TWINLOOP GUIDE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.