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EmpowerCTA®+ Injector System

FDA UDI

Class II (US FDA UDI)

by Bracco Injeneering

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 (Onyx) GTIN : 37630039300761 // Alternate : 1 x Remote Control GTIN : 37630039300471 1 x EmpowerSync® Power Supply GTIN : 37630039300839 1 x Injector GTIN : 37630039300891 FDA UDI
Model / Reference
017285 FDA UDI
Description
Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 x Remote Control GTIN : 37630039300471 1 x EmpowerSync® Power Supply GTIN : 37630039300839 1 x Injector GTIN : 37630039300891 FDA UDI

Identifiers

Catalog Number
017285 FDA UDI
Primary DI / UDI-DI
47630039300904 FDA UDI
FDA Product Code
IZQ FDA UDI
JAK FDA UDI
DSB 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
870.2770 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

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Manufacturer

Manufacturer
Bracco Injeneering

Sources (1)

  • FDA UDI 856fc2a0-4db5-4781-ba7b-8e88f4367dff 36 fields · synced May 30, 2026