Identity
- Trade Name
- TheraBionic P1 FDA UDI
- Generic Name
- Alternating electric field antimitotic cancer treatment system generator FDA UDI
- Model / Reference
- THBC P1 1.1-US-HDE FDA UDI
Identifiers
- Catalog Number
- THBC P1 1.1-US-HDE FDA UDI
- Primary DI / UDI-DI
- 04251867200072 FDA UDI
- PMA Number
- H220001 FDA UDI
- FDA Product Code
- QOM FDA UDI
- GMDN Term
- Alternating electric field antimitotic cancer treatment system generator FDA UDI
Classification
- 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Alternating electric field antimitotic cancer treatment system generator
TheraBionic P1 by TheraBionic GmbH — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- TheraBionic GmbH
Sources (1)
- FDA UDI 87616896-6c76-4240-8307-41868f278f43 36 fields · synced May 31, 2026