| Primary Device ID | 00858177007908 |
| NIH Device Record Key | dde6c140-501e-4b78-a981-2aad8f2cd170 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Audicus |
| Version Model Number | ONE |
| Catalog Number | 93336-014 |
| Company DUNS | 002345767 |
| Company Name | INTRICON CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com | |
| Phone | 651-636-9770 |
| udi@intricon.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858177007908 [Primary] |
| OSM | Hearing Aid, Air-Conduction With Wireless Technology, Prescription |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-18 |
| Device Publish Date | 2022-11-10 |
| 00858177007915 | Wireless Hearing Aid |
| 00858177007908 | Wireless Hearing Aid |
| 00858177007892 | Wireless Hearing Aid |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AUDICUS 85761588 4350257 Live/Registered |
Audicus, Inc. 2012-10-23 |