Identity
- Trade Name
- Accessory Box AB05 FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Accessory box Sentiero Screening Content: 1. Transparent Lurex Box 11 compartments. AN100336 2. Ear tip ET-03 5 mm. AN100063 3. Ear tip Lamella 6-10mm, blue AN100064 4. Ear Tip, Lamella 8-11mm. AN100144 5. Ear tip ET-11 Lamella 12-16mm. AN100125 6. Probe Tip 'Adult' for Children & Adults. AN100013 7. EarTip Soft ET-16 10mm. AN100838 8. Ear tip Soft ET-17 14 mm. AN100839 9. Ear tip Soft ET-14 18mm. AN100230 10. Test cavity for EP-DP and EP-TE with Ear Probe Tip A. AN100129 11. Cleaning tool. AN100151 FDA UDI
- Model / Reference
- 100676 FDA UDI
- Description
- Accessory box Sentiero Screening Content: 1. Transparent Lurex Box 11 compartments. AN100336 2. Ear tip ET-03 5 mm. AN100063 3. Ear tip Lamella 6-10mm, blue AN100064 4. Ear Tip, Lamella 8-11mm. AN100144 5. Ear tip ET-11 Lamella 12-16mm. AN100125 6. Probe Tip 'Adult' for Children & Adults. AN100013 7. EarTip Soft ET-16 10mm. AN100838 8. Ear tip Soft ET-17 14 mm. AN100839 9. Ear tip Soft ET-14 18mm. AN100230 10. Test cavity for EP-DP and EP-TE with Ear Probe Tip A. AN100129 11. Cleaning tool. AN100151 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223141751 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
- 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
Yes
FDA UDI
Category: Evoked-potential audiometer
Accessory Box AB05 by PATH medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 e97d7552-aaab-4f72-a8c3-77daeefccf19 33 fields · synced Jun 7, 2026