Medical device shortage: Aet-100 audion et dilation system

The Aet-100 audion et dilation system is currently reported as a medical device shortage under sections 62.21 to 62.26 of the Medical Devices Regulations. For a full list of shortages, refer to the list of shortages and discontinuations.

Details of the medical device shortage report

Report information	Details
Posted date Table Footnote 1	2024-12-02
Type of report	Actual medical device shortage
Name of medical device, if applicableTable Footnote 2	Aet-100 audion et dilation system
Other names (for example, trade name), if applicable	n/a
Package descriptionTable Footnote 3	1 each/pouch/box
Class of medical device (I, II, III or IV), if known	II
Device identifier(s)Table Footnote 4	AET-100
Medical device licence number (for Class II, III and IV), if known	109804
Authorization identification number,Table Footnote 5 if applicable	n/a
Single-use product	Yes
Importers that have reported the shortage,Table Footnote 6 if applicable	Stryker Canada
Manufacturer’s name	Entellus Medical Inc.
Manufacturer’s mailing address	3600 Holly Lane North #40 Plymouth, MN, 55447, United States
Reason for shortage	Disruption of the manufacturing of a medical device
Comments	n/a