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EmpowerCTA®+ Injector System 1731 ed03

FDA UDIEUDAMED

Class II (US FDA UDI)

by Bracco Injeneering

Identity

Trade Name
EmpowerCTA®+ Injector System 1731 ed03 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
47630039301444 FDA UDI
FDA Product Code
IZQ FDA UDI
JAK 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 UDI
892.1750 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

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

Category: CT contrast medium injection system, line-powered, stationary

EmpowerCTA®+ Injector System 1731 ed03 by Bracco Injeneering — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as CT contrast medium injection system, line-powered, stationary.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bracco Injeneering

Sources (2)

  • FDA UDI 555a4765-2e0f-4fe7-8efc-09c5bdf15a9e 34 fields · synced May 30, 2026
  • EUDAMED 1 fields · synced May 29, 2026