Identity
- Trade Name
- Aurix Insert Earphones FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- ER-3A insert earphones for use as an accessory with the Aurix system (DI: 00627908080011) The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL) FDA UDI
- Model / Reference
- ER-3A-AUX FDA UDI
- Description
- ER-3A insert earphones for use as an accessory with the Aurix system (DI: 00627908080011) The UDI is comprised of: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627908080066 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
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
Yes
FDA UDI
Aurix Insert Earphones by Vivosonic Inc — 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
- Vivosonic Inc
Sources (1)
- FDA UDI ccc5e6f8-d60a-440d-a54f-28b559144fb7 34 fields · synced Jun 8, 2026