Audion ET dilation system

GUDID 00850002250428

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.

ENTELLUS MEDICAL, INC.

Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use Eustachian catheter, single-use

• Primary Device ID: 00850002250428
• NIH Device Record Key: 1fae9230-1ff7-4598-a91d-20716dcbd3cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Audion ET dilation system
• Version Model Number: AET-100
• Company DUNS: 017283879
• Company Name: ENTELLUS MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850002250428 [Primary]

FDA Product Code

• PNZ: Eustachian Tube Balloon Dilation Device

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-13
• Device Publish Date: 2022-06-03

Devices Manufactured by ENTELLUS MEDICAL, INC.

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• 00850002250251 - TGS: 2023-07-07 Universal Headrest Adapter A
• 00850002250268 - TGS: 2023-07-07 Universal Headrest Adapter B
• 00850002250275 - TGS: 2023-07-07 Universal Headrest Adapter C
• 00857326005567 - FocESS: 2023-07-07 HD Wireless Camera
• 00857326005581 - Portable Red LED Light Source: 2023-07-07 LED light source, red
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