Medical device licence · 92396 · Class 3
DIEGO ELITE
Yes: licensed in Canada
Licence status Issued (active); first licensed December 5, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 92396
- Licence holder
- Gyrus Acmi, IncWestborough, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 5, 2013
- Devices covered
- 23
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DIEGO ELITE BLADE, BIPOLAR
- DIEGO ELITE BURR
- DIEGO ELITE DRILL - BURR, DIAMOND CRSE, FIXED EXPOSURE
- DIEGO ELITE DRILL - BURR, DIAMOND FINE, FIXED EXPOSURE
- DIEGO ELITE DRILL - BURR, DIAMOND FINE, VAR EXPOSURE
- DIEGO ELITE DRILL - BURR, ROUND CUTTING, FIXED EXPOSURE
- DIEGO ELITE DRILL - BURR, ROUND CUTTING, VAR EXPOSURE
- DIEGO ELITE DRILL - CLEANING KIT NONSTERILE FOR DRILL, ATTACHMENTS
- DIEGO ELITE DRILL - DRILL ATTACHMENT ANGLED
- DIEGO ELITE DRILL - DRILL ATTACHMENT STAPES
- DIEGO ELITE DRILL - DRILL ATTACHMENT STRAIGHT
- DIEGO ELITE DRILL - DRILL HANDPIECE BASE
- DIEGO ELITE DRILL - IRRIGATION CLIP
- DIEGO ELITE DRILL - STAPES BURR, ROUND DIAMOND
- DIEGO ELITE DRILL - STERILIZATION TRAY DRILL, ATTACHMENTS TRAY
- DIEGO ELITE DRILL - TUBESET STANDARD IRRIGATION/SUCTION
- DIEGO ELITE FOOTSWITCH
- DIEGO ELITE MULTIDEBRIDER HANDPIECE
- DIEGO ELITE POWER CONSOLE
- DIEGO ELITE SHAVER BLADE
- DIEGO ELITE SUCTION MODULE
- DIEGO ELITE TUBESET
- DIEGO ELITE TUBING
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “diego”. A notice may cover another product or only some lots: read it to see what it covers.
- Diego Elite Tubeset (2015-05-04)May 26, 2015 · Medical devices · Health products · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.