Medical device licence · 95105 · Class 4
OSTEOCONDUCTIVE BONE SUBSTITUTE - BOVINE
Yes: licensed in Canada
Licence status Issued (active); first licensed May 8, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95105
- Licence holder
- Nibec Co., Ltd.Iwol-Myeon, Jincheon-Gun, South Korea
- Risk class
- Class IV (highest risk)
- Licence type
- Device Family
- First licensed
- May 8, 2015
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CREOS XENOGAIN BOVINE BONE MINERAL MATRIX, BOWL
- CREOS XENOGAIN BOVINE BONE MINERAL MATRIX, SYRINGE
- CREOS XENOGAIN BOVINE BONE MINERAL MATRIX, VIAL
- NEODENT XENOGRAFT
- OCS-B OSTEOCONDUCTIVE SUBSTITUTE-BOVINE CANCELLOUS BONE
- OCS-B OSTEOCONDUCTIVE SUBSTITUTE-BOVINE CORTICAL BONE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.