Identity
- Trade Name
- VivoTab Electrode (3 pack) FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Electrodes for use with the Integrity and Aurix system (DI: 00627908020017 and 00627908080011respectively). The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10) FDA UDI
- Model / Reference
- 100001 FDA UDI
- Description
- Electrodes for use with the Integrity and Aurix system (DI: 00627908020017 and 00627908080011respectively). The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627908070050 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
VivoTab Electrode (3 pack) 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 78efa17e-ee53-44a3-88a3-640a850caa6d 34 fields · synced May 30, 2026