Identity
- Trade Name
- Accessory Box AB02 FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Accessory set including: 1 pc. 100013 Probe Tip PT-A 1 pc. 100219 Test Cavity for PT-A 5pcs. 100063 Ear Tip ET-03 5pcs. 100064 Ear Tip ET-10 5pcs. 100125 Ear Tip ET-11 5pcs. 100126 Ear Tip Soft ET-12 5pcs. 100144 Ear Tip ET-13 3pcs. 100230 Ear Tip Soft ET-14 1pc 100151 Cleaning Tool CT-01 FDA UDI
- Model / Reference
- 100207 FDA UDI
- Description
- Accessory set including: 1 pc. 100013 Probe Tip PT-A 1 pc. 100219 Test Cavity for PT-A 5pcs. 100063 Ear Tip ET-03 5pcs. 100064 Ear Tip ET-10 5pcs. 100125 Ear Tip ET-11 5pcs. 100126 Ear Tip Soft ET-12 5pcs. 100144 Ear Tip ET-13 3pcs. 100230 Ear Tip Soft ET-14 1pc 100151 Cleaning Tool CT-01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223140723 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 AB02 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 a3b82a09-aa36-487c-bdc1-47d1e989096b 33 fields · synced Jun 1, 2026