Medical device licence · 65398 · Class 3
UNIVERSAL NEURO SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 6, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 65398
- Licence holder
- Stryker Leibinger Gmbh & Co. KgKalamazoo, MI, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 6, 2004
- Devices covered
- 31
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AXS SCREWDRIVER BLADE
- BOX PLATE, 4X2 HOLES
- DOUBLE-Y PLATE, 6 HOLES, BAR
- GAP PLATE
- GAP PLATE, 8 HOLES
- LOW PROFILE 3-D BOX PLATE 2X2 HOLES
- LOW PROFILE DOUBLE-Y-PLATE 7 HOLES
- LOW PROFILE PLATE WITH BAR, 2 HOLES, BAR
- LOW PROFILE PLATE, CURVED, 10 HOLES
- LOW PROFILE T-PLATE 7 HOLES
- LOW PROFILE Y-PLATE 10 HOLES
- PLATE, BAR, WITH TAB 2 HOLES, BAR
- SCREWDRIVER BLADE
- SCREWDRIVER BLADE EMERGENCY
- STRAIGHT PLATE, 2 HOLES, BAR
- STRAIGHT PLATE, BAR, WITH TAB, 2 HOLES, BAR
- UN3 BURR HOLE COVER, WITH TAB
- UNIV NEURO SYST- NEURO SCREWS/DEL. DISCS,STERILE,PRE-LOADED SELF-DRILLING
- UNIV. NEURO SYS-NEURO SCREWS/DEL DISCS STERILE, PRELOADED SELF-TAPPING
- UNIVERSAL NEURO III SCREW DISC, SELF-DRILLING
- UNIVERSAL NEURO III SCREW DISC, SELF-TAPPING
- UNIVERSAL NEURO SYSTEM - BURR HOLE COVERS
- UNIVERSAL NEURO SYSTEM - DRILL BITS
- UNIVERSAL NEURO SYSTEM - EMPTY SCREW DISC FOR SELF DRILLING
- UNIVERSAL NEURO SYSTEM - LOW PROFILE BURR HOLE COVERS
- UNIVERSAL NEURO SYSTEM - NEURO PLATES/MESH LOW PROFILE PLATES
- UNIVERSAL NEURO SYSTEM - SELF-TAPPING SCREWS
- UNIVERSAL NEURO SYSTEM - SKULL BASE PLATE
- UNIVERSAL NEURO SYSTEM EMERGENCY SCREWS
- UNIVERSAL NEURO SYSTEM- NEURO SCREWS, CROSS-PIN, SELF-DRILLING
- UNIVERSAL NEURO SYSTEM-SELF-DRILLING SCREWS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.