EmpowerCTA+ Injector System 017285

GUDID 47630039301949

Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector

Bracco Injeneering SA

CT contrast medium injection system, line-powered, stationary
Primary Device ID47630039301949
NIH Device Record Keyc88196e7-be8d-480a-882e-f1e64f9ca249
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmpowerCTA+ Injector System
Version Model Number017285
Catalog Number017285
Company DUNS482489007
Company NameBracco Injeneering SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS147630039301949 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAKSystem, X-Ray, Tomography, Computed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-13
Device Publish Date2024-02-05

On-Brand Devices [EmpowerCTA+ Injector System]

47630039302014Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector
47630039301949Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.