Medical device licence · 85536 · Class 2
FIBER OPTIC INSTRUMENTS
Yes: licensed in Canada
Licence status Issued (active); first licensed March 21, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 85536
- Licence holder
- Integra Lifesciences Production CorporationMansfield, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- March 21, 2011
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIGG MAMMAPLASTY RETRACTOR, FIBER OPTIC
- BIGGS FACE LIFT RETRACTOR, FIBER OPTIC
- DEAVER RETRACTOR, FIBER OPTIC
- FERREIRA BREAST AUGMENTATION RETRACTOR, FIBER OPTIC
- FERREIRA FACE LIFT RETRACTOR, FIBER OPTIC
- KILLIAN SPECULUM, FIBER OPTIC
- PADGETT-DEAVER RETRACTOR, FIBER OPTIC
- TBTS-STYLE W/SUCTION PORT WITH TEETH
- TBTS-STYLE W/SUCTION PORT WITHOUT TEETH
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.