ER-3A insert earphones for use as an accessory with the Aurix system (DI: 00627908080011) The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) +…
ER-3A insert earphones for use as an accessory with the Aurix system (DI: 00627908080011) The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Aurix Insert Earphones | Listed by | Vivosonic Inc., Canada |
| FDA product code | GWJ |
| Device type | Stimulator, Auditory, Evoked Response |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1900 |
| Establishment | Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2020-04-21 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2020-04-20 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.