Identity
- Trade Name
- Nerivio FDA UDI
- Generic Name
- Craniofacial analgesia electrical stimulator FDA UDI
- Device Name
- Refill pack for Nerivio device FDA UDI
- Model / Reference
- FGD000075 FDA UDI
- Description
- Refill pack for Nerivio device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290017578026 FDA UDI
- FDA Product Code
- QGT FDA UDI
- GMDN Term
- Craniofacial analgesia electrical stimulator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5899 FDA UDI
- Commercial Distribution
- 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Craniofacial analgesia electrical stimulator
Nerivio by Theranica Bio-Electronics, Ltd. — 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
- Theranica Bio-Electronics, Ltd.
Sources (1)
- FDA UDI 0fba07f1-db7d-4e1b-aa15-1b5fbeb483e8 35 fields · synced May 30, 2026