COEUR, INC.

Address:209 Creekside Dr,WASHINGTON,NC,27889,US

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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 And Syringe, Angiographic (DXT) (10)

Premarket Exempt

Clear

Coeur - M297701550 Catalog Number : C853-0155

Device Description : Coeur 150mL Syringe w/ J tube

Device Class : 2

Duns Number: 132515441

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

Coeur - M297702100 Catalog Number : C853-0210

Device Description : Coeur 200mL Syringe

Device Class : 2

Duns Number: 132515441

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

Coeur - M297702110 Catalog Number : C853-0211

Device Description : 200mL Front Load Ct-Pack with Coiled Line

Device Class : 2

Duns Number: 132515441

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

Coeur - M297702320 Catalog Number : C853-0232

Device Description : 200mL Front Load CT Syringe with Fill Tube

Device Class : 2

Duns Number: 132515441

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

Coeur - M297722010 Catalog Number : C853-2201

Device Description : MR Syringe Dual Pack for Spectris Solaris Injectors (Includes; 1-65mL Syringe, 1 MR Syringe Dual Pack for Spectris Solaris Injectors (Includes; 1-65mL Syringe, 1-115mL Syringe, 1-96" Y-Line, and 2 Spikes)

Device Class : 2

Duns Number: 132515441

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

Coeur - M297722070 Catalog Number : C853-2207

Device Description : MR Syringe Dual Pack for Spectris Solaris Injectors (Includes; 2-65mL Syringes, MR Syringe Dual Pack for Spectris Solaris Injectors (Includes; 2-65mL Syringes, 1-96" Y-Line and 2 Spikes)

Device Class : 2

Duns Number: 132515441

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

Coeur - M297731020 Catalog Number : C853-3102

Device Description : 200mL Single Syringe Kit for Stellant Injectors (Includes 1-200mL Syringes, 1-6 200mL Single Syringe Kit for Stellant Injectors (Includes 1-200mL Syringes, 1-60" Y-line, and 1 Spike

Device Class : 2

Duns Number: 132515441

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

Coeur - M297732010 Catalog Number : C853-3201

Device Description : 200mL Dual-Syringe Kit for Stellant Injectors (Includes 2-200mL Syringes, 1-60" 200mL Dual-Syringe Kit for Stellant Injectors (Includes 2-200mL Syringes, 1-60" Y-line, and 2-Spikes

Device Class : 2

Duns Number: 132515441

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

Coeur - M297732020 Catalog Number : C853-3202

Device Class : 2

Duns Number: 132515441

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

Coeur - M297761500 Catalog Number : C853-6150

Device Description : 150mL A-Series Syringe

Device Class : 2

Duns Number: 132515441

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

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