ApprovalTrail

Medical device licence · 78993 · Class 2

CORNEA BLADES

Yes: licensed in Canada

Licence status Issued (active); first licensed February 5, 2009. It is in Health Canada’s list of active licences.
Licence number
78993
Licence holder
Katena Products, Inc.Parsippany, NJ, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
February 5, 2009
Devices covered
6

Devices on this licence

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

  • ADVANCUT CLEAR CORNEA ANGLED BLADE
  • ADVANCUT SIDEPORT BLADE
  • ADVANCUT STAB
  • CLEAR CORNEA SAFETY BLADE
  • KELLAN SUTURELESS INCISION BLADE
  • KELLAN SUTURELESS INCISION BLADE/HANDLE

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