Identity
- Trade Name
- EmpowerCTA®+ Injector System with EDA FDA UDI
- Generic Name
- CT contrast medium injection system, line-powered, stationary FDA UDI
- Device Name
- Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Remote Control GTIN : 37630039300471 1 x EDA Module Kit GTIN : 37630039300426 1 x EmpowerSync® Power Supply GTIN : 37630039300488 1 x Injector GTIN : 37630039300747 FDA UDI
- Model / Reference
- 017383 FDA UDI
- Description
- Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Remote Control GTIN : 37630039300471 1 x EDA Module Kit GTIN : 37630039300426 1 x EmpowerSync® Power Supply GTIN : 37630039300488 1 x Injector GTIN : 37630039300747 FDA UDI
Identifiers
- Catalog Number
- 017383 FDA UDI
- Primary DI / UDI-DI
- 47630039300447 FDA UDI
- FDA Product Code
- DSB FDA UDIJAK FDA UDIIZQ FDA UDI
- GMDN Term
- CT contrast medium injection system, line-powered, stationary FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2770 FDA UDI892.1750 FDA UDI870.1650 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
Yes
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 with EDA 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 2d5a3085-7214-4f3c-b257-48ea36d06d12 36 fields · synced Jun 8, 2026