Identity
- Trade Name
- SEDECAL FDA UDI
- Generic Name
- Diagnostic x-ray system generator, stationary FDA UDI
- Device Name
- High frequency diagnostic x-ray generator FDA UDI
- Model / Reference
- HERCULES-40 FDA UDI
- Description
- High frequency diagnostic x-ray generator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08436046001411 FDA UDI
- FDA Product Code
- IZO FDA UDI
- GMDN Term
- Diagnostic x-ray system generator, stationary FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1700 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sedecal by Sedecal., Sa. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Sedecal., Sa.
Sources (1)
- FDA UDI aa1b2fb3-1c24-495d-8412-e38da3f6d9f3 35 fields · synced May 30, 2026