Bracco Injeneering SA

Address:AVENUE DE SEVELIN 46,LAUSANNE Vaud,CH

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Injector, Contrast Medium, Automatic (IZQ) (7) System, X-Ray, Tomography, Computed (JAK) (6) Plethysmograph, Impedance (DSB) (3)

Premarket Exempt

Clear

EmpowerCTA®+ Injector System - 47630039300782 Catalog Number : 017285

Device Description : Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 x Remote Control GTIN : 376300393004711 x EmpowerSync® Power Supply GTIN : 376300393008391 x Injector GTIN : 37630039300822

Device Class : 2

Duns Number: 482489007

Premarket Exempt : No

Product Code : DSB, JAK, IZQ

Prescription Use : Yes

Device Count : 1

EmpowerCTA®+ Injector System with EDA - 47630039300812 Catalog Number : 017383

Device Description : Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Remote Control GTIN : 376300393004711 x EDA Module Kit GTIN : 376300393004261 x EmpowerSync® Power Supply GTIN : 376300393008391 x Injector GTIN : 37630039300822

Device Class : 2

Duns Number: 482489007

Premarket Exempt : No

Product Code : IZQ, DSB, JAK

Prescription Use : Yes

Device Count : 1

EmpowerCTA®+ Injector System - 47630039300904 Catalog Number : 017285

Device Class : 2

Duns Number: 482489007

Premarket Exempt : No

Product Code : IZQ, JAK, DSB

Prescription Use : Yes

Device Count : 1

EmpowerMR® Injector System without Remote Control - 47630039300973 Catalog Number : 017377

Device Description : Composed of:1 x Hydraulic Controller1 x Injector Head1 x Electro-Hydraulic Interconnect

Device Class : 2

Duns Number: 482489007

Premarket Exempt : No

Product Code : IZQ

Prescription Use : Yes

Device Count : 1

EmpowerCTA®+ Injector System - 47630039301000 Catalog Number :

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

Device Class : 2

Duns Number: 482489007

Premarket Exempt : No

Product Code : IZQ, JAK

Prescription Use : Yes

Device Count : 1

EmpowerCTA®+ Injector System - 47630039301437 Catalog Number : 017285

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

Device Class : 2

Duns Number: 482489007

Premarket Exempt : No

Product Code : IZQ, JAK

Prescription Use : Yes

Device Count : 1

EmpowerCTA®+ Injector System 1731 ed03 - 47630039301444 Catalog Number :

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

Device Class : 2

Duns Number: 482489007

Premarket Exempt : No

Product Code : IZQ, JAK

Prescription Use : Yes

Device Count : 1

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