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Accessory Box Sentiero Ear Tips All Sizes for PT-A (Grason)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Accessory Box Sentiero Ear Tips All Sizes for PT-A (Grason) FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 100734 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223141775 FDA UDI
- FDA Product Code
- GWJ FDA UDI
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1900 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Accessory Box Sentiero Ear Tips All Sizes for PT-A (Grason) by PATH medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- PATH medical GmbH
Sources (1)
- FDA UDI 1ccc3a7d-0524-49f1-9cab-a36fb7ea46fb 34 fields · synced May 30, 2026