Accessory box Content: 1. Box. AN101329 2. Ear Tip PM009 9 mm mushroom. AN100767-P 3. Ear Tip PM010 10 mm mushroom. AN100768-P 4. Ear Tip PM011 11 mm mushroom. AN100769-P 5. Ear Tip PM012…
Accessory box Content: 1. Box. AN101329 2. Ear Tip PM009 9 mm mushroom. AN100767-P 3. Ear Tip PM010 10 mm mushroom. AN100768-P 4. Ear Tip PM011 11 mm mushroom. AN100769-P 5. Ear Tip PM012 12 mm mushroom. AN100770-P 6. Ear Tip PM013 13 mm mushroom. AN100771-P 7. Ear Tip PM014 14 mm mushroom. AN100772-P 8. Ear Tip ET-21 18 mm mushroom. AN100577
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 Accessory Box AB09 | Listed by | Path, Germany |
| FDA product code | GWJ |
| Device type | Stimulator, Auditory, Evoked Response |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1900 |
| Establishment | Manufacturer |
| Record published | 2023-11-14 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | manufacturing date |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
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.