Identity
- Trade Name
- Bio-logic FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- OAE Ear Probe Assembly FDA UDI
- Model / Reference
- OAE Ear Probe FDA UDI
- Description
- OAE Ear Probe Assembly FDA UDI
Identifiers
- Catalog Number
- 580-PROAE3, 29402 FDA UDI
- Primary DI / UDI-DI
- 00382830000543 FDA UDI
- FDA Product Code
- EWO FDA UDIGWJ FDA UDI
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1050 FDA UDI882.1900 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Bio-logic by Natus Medical Incorporated — 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
- Natus Medical Incorporated
Sources (1)
- FDA UDI e7b31c8d-7d4b-424f-a9cf-a7c13b373a5c 36 fields · synced May 30, 2026