| Primary Device ID | 10850065321018 |
| NIH Device Record Key | 42e51206-20cf-4ef0-8f2a-889eb97d12cf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ceretone |
| Version Model Number | Nexus |
| Company DUNS | 118836847 |
| Company Name | Audicon 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 | true |
| 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 | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850065321011 [Primary] |
| GS1 | 10850065321018 [Package] Contains: 00850065321011 Package: [2 Units] In Commercial Distribution |
| GS1 | 20850065321015 [Package] Package: [20 Units] In Commercial Distribution |
| GS1 | 30850065321012 [Package] Contains: 20850065321015 Package: Pallet [12 Units] In Commercial Distribution |
| GS1 | 40850065321019 [Package] Contains: 00850065321011 Package: Case [40 Units] In Commercial Distribution |
| QUF | Hearing Aid, Air-Conduction, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-01 |
| Device Publish Date | 2024-07-24 |
| 00860010331026 | OTC Rechargeable Hearing Aid |
| 10850065321018 | OTC Hearing Aid |
| 20860010331099 | OTC Hearing Aid |
| 10860010331030 | OTC Hearing Aid |
| 10860010331078 | OTC Rechargeable Hearing Aid |
| 10860010331061 | OTC Rechargeable Hearing Aid |
| 00860010331057 | OTC Rechargeable Hearing Aid |
| 10860010331009 | OTC Rechargeable Hearing Aid |
| 10850065321308 | OTC Rechargeable Hearing Aid |
| 10850065321292 | OTC Rechargeable Hearing Aid |
| 10850065321285 | Essential |
| 10850065321261 | OTC Rechargeable Hearing Aid |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CERETONE 90403460 not registered Live/Pending |
Ceretone Corp 2020-12-22 |