Medical device licence · 12508 · Class 4
HUMAN DEMINERALIZED BONE
Yes: licensed in Canada
Licence status Issued (active); first licensed September 24, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 12508
- Licence holder
- Isotis Orthobiologics, Inc.Irvine, CA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- Device Family
- First licensed
- September 24, 1999
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACCELL CONNEXUS
- DYNAGRAFT II GEL
- DYNAGRAFT II PUTTY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.