Content: 1. Earplugs 5-8 mm PM105 2. Earplugs 6 mm PM006 3. Earplugs 7 mm PM007 4. Earplugs 8 mm PM008 5. Earplugs 9 mm PM009 6. Earplugs 10 mm PM010 7. Earplugs 16 mm PM016 8. Earplugs…
Content: 1. Earplugs 5-8 mm PM105 2. Earplugs 6 mm PM006 3. Earplugs 7 mm PM007 4. Earplugs 8 mm PM008 5. Earplugs 9 mm PM009 6. Earplugs 10 mm PM010 7. Earplugs 16 mm PM016 8. Earplugs 11-15 mm PM111 9. Earplugs 18,5 mm PM018 10. Earplugs 7-11 mm PM107 11. Earplugs 11 mm PM011 12. Earplugs 12 mm PM012 13. Earplugs 13 mm PM013 14. Earplugs 14 mm PM014 PATH MEDICAL is not manufacturer or Labeler of this product. The legal manufacturer confirmed to submit his UDI once stablished.
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 Sentiero Ear Tips All Sizes for PT-A (Grason) | 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 | 2016-08-31 |
| Record revised | 2018-03-29 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Distribution end date | 2017-01-25 |
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.