COEUR, INC.

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

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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 And Syringe, Angiographic (DXT) (7)

Premarket Exempt

Clear

Coeur Nemoto - M902552020 Catalog Number : C855-5202

Device Description : Nemoto 200ml w/ coiled line and fill tube

Device Class : 2

Duns Number: 132515441

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

Coeur Nemoto - M902552060 Catalog Number : C855-5206

Device Description : 200mL Disposable CT Syringe Includes (1) 60” Coiled Extension Line / (1) Fill Spike

Device Class : 2

Duns Number: 132515441

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

Coeur Nemoto - M902552580 Catalog Number : C855-5258

Device Description : 200mL /50mL Disposable CT Dual Syringe Pack includes (1) Y-Set / (1) Check Valve 200mL /50mL Disposable CT Dual Syringe Pack includes (1) Y-Set / (1) Check Valve / (2) Spikes

Device Class : 2

Duns Number: 132515441

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

Coeur Nemoto - M902553040 Catalog Number : C855-5304

Device Description : Nemoto 100ml/200mL Dual Pack w/ fill tube

Device Class : 2

Duns Number: 132515441

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

Coeur Nemoto - M902553080 Catalog Number : C855-5308

Device Description : 200mL /100mL Disposable CT Dual Syringe Pack includes (1) Y-Set / (1) Check Valv 200mL /100mL Disposable CT Dual Syringe Pack includes (1) Y-Set / (1) Check Valve / (2) Spikes

Device Class : 2

Duns Number: 132515441

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

Coeur Nemoto - M902554040 Catalog Number : C855-5404

Device Description : Nemoto 200ml/200mL Dual Pack w/ fill tube

Device Class : 2

Duns Number: 132515441

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

Coeur Nemoto - M902554080 Catalog Number : C855-5408

Device Description : 200mL/200mL CT Dual Syringe Pack Includes (1) Y-set /(1) Check Valve / (2) Spikes

Device Class : 2

Duns Number: 132515441

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

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