Aurix software for use with the Aurix system (DI: 00627908080011) The UDI for software is comprised of the following: GTIN + Additional Product Identification Assigned by the Manufacturer…
Aurix software for use with the Aurix system (DI: 00627908080011) The UDI for software is comprised of the following: GTIN + Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) (which represents the software version) UDI Application Identifier for Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) = 240
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 Software | 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 |
| 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.