| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00850002250428 [Primary] |
| PNZ | Eustachian Tube Balloon Dilation Device |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-13 |
| Device Publish Date | 2022-06-03 |
| 00850002250237 - TGS | 2023-07-07 Universal Headrest |
| 00850002250244 - TGS | 2023-07-07 Universal Headrest Mounting Arm |
| 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 |
| 00857326005536 - XeroGel | 2023-07-07 Nasal Epistaxis 2 Pack |