Medical device licence · 66816 · Class 2

ELECTRIC PEN DRIVE (E-PEN)

Yes: licensed in Canada

Licence status Issued (active); first licensed December 9, 2004. It is in Health Canada’s list of active licences.

Licence number: 66816
Licence holder: Synthes GmbhOberdorf, Switzerland
Risk class: Class II (low to moderate risk)
Licence type: System
First licensed: December 9, 2004
Devices covered: 62

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

E-PEN - ADAPTOR
E-PEN - ADAPTOR FOR INTRA COUPLING
E-PEN - BASIC CONSOLE
E-PEN - BROACH ATTACHMENT
E-PEN - BURR ACORN-SHAPED
E-PEN - BURR ATTACHMENT
E-PEN - BURR BARREL-SHAPED
E-PEN - BURR CIRCULAR WITH J-LATCH COUPLING
E-PEN - BURR CIRCULAR WITH MINI QUICK COUPLING
E-PEN - BURR CONICAL WITH J-LATCH COUPLING
E-PEN - BURR CONICAL WITH MINI QUICK COUPLING
E-PEN - BURR CRANIAL
E-PEN - BURR CYLINDRICAL FISSURE
E-PEN - BURR DRUM-SHAPED
E-PEN - BURR EGG-SHAPED
E-PEN - BURR EGG-SHAPED WITH J-LATCH COUPLING
E-PEN - BURR EGG-SHAPED WITH MIN QUICK COUPLING
E-PEN - BURR INVERTED CONE
E-PEN - BURR PEAR-SHAPED
E-PEN - BURR PEAR-SHAPED WITH J-LATCH COUPLING
E-PEN - BURR PEAR-SHAPED WITH MINI QUICK COUPLING
E-PEN - BURR PIN-SHAPED
E-PEN - BURR ROUND
E-PEN - BURR ROUND DIAMOND COATED
E-PEN - BURR ROUND WITH J-LATCH COUPLING
E-PEN - BURR ROUND WITH MINI QUICK COUPLING
E-PEN - BURR TAPERED FISSURE
E-PEN - BURR TAPERED FISSURE WITH J-LATCH COUPLING
E-PEN - BURR TAPERED FISSURE WITH MINI QUICK COUPLING
E-PEN - CABLE
E-PEN - CONTR-ANGLE ATTACHMENT
E-PEN - CRANIOTOME
E-PEN - DRILL ATTACHMENT
E-PEN - DRILL BIT
E-PEN - DRILL BIT WIRE-PASS
E-PEN - ELECTRIC PEN DRIVE
E-PEN - FOOTSWITCH
E-PEN - HAND SWITCH FOR ELECTRIC PEN DRIVE
E-PEN - IRRIGATION NOZZLE FOR ELECTRIC PEN DRIVE
E-PEN - IRRIGATION NOZZLE FOR OSCILLATING SAW ATTACHMENT
E-PEN - IRRIGATION NOZZLE FOR PERFORATOR
E-PEN - IRRIGATION NOZZLE FOR RECIPROCATING SAW ATTACHMENT
E-PEN - IRRIGATION NOZZLE FOR SAGITTAL SAW ATTACHMENT
E-PEN - IRRIGATION TUBING
E-PEN - K-WIRE ATTACHMENT
E-PEN - LINDEMANN REAMER
E-PEN - LINDEMANN REAMER WITH J-LATCH COUPLING
E-PEN - LINDEMANN REAMER WITH MINI QUICK COUPLING
E-PEN - NEURO
E-PEN - OSCILLATING DRILL ATTACHMENT
E-PEN - OSCILLATING SAW ATTACHMENT
E-PEN - PERFORATOR
E-PEN - POWER CORD
E-PEN - RASP
E-PEN - RECIPROCATING SAW ATTACHMENT
E-PEN - SAGITTAL SAW ATTACHMENT
E-PEN - SAW BLADE
E-PEN - SCREW ATTACHMENT
E-PEN - STANDARD CONSOLE WITH IRRIGATION
E-PEN - STANDARD CONSOLE WITHOUT IRRIGATION
E-PEN - SWANSON BURR
STANDARD CONSOLE WITHOUT TORQUE LIMITING IRRIGATION

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.