Identity
- Trade Name
- Anthem Generator FDA UDI
- Generic Name
- Diagnostic x-ray system generator, mobile FDA UDI
- Device Name
- The Anthem Generator is intended for use as part of a radiographic stationary x-ray system. The Generator provides power and control for other parts of the system. It uses multi-pulse high frequency technology to produce waveforms near constant potential. FDA UDI
- Model / Reference
- 50-650 FDA UDI
- Description
- The Anthem Generator is intended for use as part of a radiographic stationary x-ray system. The Generator provides power and control for other parts of the system. It uses multi-pulse high frequency technology to produce waveforms near constant potential. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858340006240 FDA UDI
- FDA Product Code
- IZO FDA UDI
- GMDN Term
- Diagnostic x-ray system generator, mobile FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1700 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Diagnostic x-ray system generator, mobile
Anthem Generator by Del Medical, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Del Medical, Inc.
Sources (1)
- FDA UDI 8243db68-2048-4726-a0fe-9127f7f68b0f 34 fields · synced May 30, 2026