Identity
- Trade Name
- EmpowerCTA®+ Injector System FDA UDI
- Generic Name
- CT contrast medium injection system, line-powered, stationary FDA UDI
- Device Name
- Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector FDA UDI
- Model / Reference
- 017285 FDA UDI
- Description
- Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 47630039301000 FDA UDI
- FDA Product Code
- IZQ FDA UDIJAK FDA UDI
- GMDN Term
- CT contrast medium injection system, line-powered, stationary FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1650 FDA UDI892.1750 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
EmpowerCTA®+ Injector System by Bracco Injeneering — 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
- Bracco Injeneering
Sources (1)
- FDA UDI ab04cc05-084a-45f9-824d-93c7dd4df846 35 fields · synced May 30, 2026