Identity
- Trade Name
- Accessory Box AB09 FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- 101379-PS FDA UDI
- Description
- 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 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223146961 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 AB09 by PATH medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Evoked-potential audiometer.
- ECochG Adapters — Vivosonic Inc · Class II
- TE Tip Sample Box — Otodynamics · Class II
- Tip Sample Box (Neonate) — Otodynamics · Class II
- Otoport LCD service kit — Otodynamics · Class II
- TEOAE probe tips — Otodynamics · Class II
- ABR Case service kit - Top — Otodynamics · Class II
- Otoport ABR Binaural Upgrade Kit (TE) — Otodynamics · Class II
- ABR Test Cavity — Otodynamics · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PATH medical GmbH
Sources (1)
- FDA UDI 6ad16097-b8a5-4e0d-8de7-924615a78590 33 fields · synced May 29, 2026