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) (10) Plethysmograph, Impedance (DSB) (7) System, X-Ray, Tomography, Computed (JAK) (7)

Premarket Exempt

Clear

Floor Stand - 37630039300693 Catalog Number : 017410

Device Class : 2

Duns Number: 482489007

Premarket Exempt : No

Product Code : DSB, JAK, IZQ

Prescription Use : Yes

Device Count : 1

Floor Stand Shroud - 37630039300709 Catalog Number : 017411

Device Class : 2

Duns Number: 482489007

Premarket Exempt : No

Product Code : DSB, JAK, IZQ

Prescription Use : Yes

Device Count : 1

Accessory Kit - 37630039300730 Catalog Number : 017381

Device Class : 2

Duns Number: 482489007

Premarket Exempt : No

Product Code : IZQ

Prescription Use : Yes

Device Count : 1

EDA Clip - 37630039301737 Catalog Number :

Device Class : 2

Duns Number: 482489007

Premarket Exempt : No

Product Code : DSB, JAK, IZQ

Prescription Use : Yes

Device Count : 1

Injector Mounting Arm, Left - 37630039301805 Catalog Number : 017417

Device Class : 2

Duns Number: 482489007

Premarket Exempt : No

Product Code : DSB, JAK, IZQ

Prescription Use : Yes

Device Count : 1

Injector Mounting Arm, Right - 37630039301812 Catalog Number : 017418

Device Class : 2

Duns Number: 482489007

Premarket Exempt : No

Product Code : DSB, JAK, IZQ

Prescription Use : Yes

Device Count : 1

CT Expres™ 3D - 47630039300096 Catalog Number : 651207

Device Description : Composed of : 1 x CT Exprès™ - Injector Unit GTIN : 376300393001052 x CT Exprès™ Composed of : 1 x CT Exprès™ - Injector Unit GTIN : 376300393001052 x CT Exprès™ - Control Panel GTIN : 37630039300112

Device Class : 2

Duns Number: 482489007

Premarket Exempt : No

Product Code : IZQ

Prescription Use : Yes

Device Count : 1

EmpowerCTA®+ Injector System - 47630039300430 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 : 376300393004881 x Injector GTIN : 37630039300747

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 - 47630039300447 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 : 376300393004881 x Injector GTIN : 37630039300747

Device Class : 2

Duns Number: 482489007

Premarket Exempt : No

Product Code : DSB, JAK, IZQ

Prescription Use : Yes

Device Count : 1

EmpowerMR® Injector System without Remote Control - 47630039300751 Catalog Number : 017377

Device Description : Composed of : 1 x Electro-Hydraulic Interconnect GTIN : 376300393003651 x Hydrau Composed of : 1 x Electro-Hydraulic Interconnect GTIN : 376300393003651 x Hydraulic Controller GTIN : 376300393003891 x Injector Head GTIN : 37630039300396

Device Class : 2

Duns Number: 482489007

Premarket Exempt : No

Product Code : IZQ

Prescription Use : Yes

Device Count : 1

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