Duns Number:017283879
Device Description: The Audion ET dilation system is used to dilate the cartilaginous portion of the Eustachia The Audion ET dilation system is used to dilate the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction in patients 18 years and older using a transnasal approach.
Catalog Number
-
Brand Name
Audion ET dilation system
Version/Model Number
AET-100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PNZ
Product Code Name
Eustachian Tube Balloon Dilation Device
Public Device Record Key
1fae9230-1ff7-4598-a91d-20716dcbd3cc
Public Version Date
June 13, 2022
Public Version Number
1
DI Record Publish Date
June 03, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |