Medical device licence · 86250 · Class 3
ONE PIECE ENDOSSEOUS IMPLANTS
Yes: licensed in Canada
Licence status Issued (active); first licensed May 31, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 86250
- Licence holder
- Oco Biomedical, Inc.Albuquerque, NM, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- May 31, 2011
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- I-MICRO ONE-PIECE O-BALL IMPLANT 2.2MM
- I-MICRO ONE-PIECE O-BALL IMPLANT 2.5MM
- I-MINI ONE-PIECE O-BALL IMPLANT 3.0MM
- ISI ONE-PIECE O-BALL IMPLANT 3.25MM
- ISI ONE-PIECE O-BALL IMPLANT 4.0MM
- ISI ONE-PIECE O-BALL IMPLANT 5.0MM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.