Medical device licence · 111237 · Class 3
JAWS NITINOL STAPLE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 14, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 111237
- Licence holder
- Paragon 28, Inc.Englewood, CO, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 14, 2024
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- JAWS GREAT WHITE NITINOL STAPLE SYSTEM, STRAIGHT STAPLE KIT
- JAWS NITINOL STAPLE SYSTEM, ANGLED STAPLE KIT
- JAWS NITINOL STAPLE SYSTEM, JAWS TRIAL SIZER
- JAWS NITINOL STAPLE SYSTEM, STRAIGHT STAPLE KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.