NEMOTO KYORINDO CO.,LTD.

Address:2-12-23 Aoki,KAWAGUCHI-SHI Saitama,JP

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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) (3) Injector, Contrast Medium, Automatic (IZQ) (1)

Premarket Exempt

Clear

SONIC SHOT GX - 04560138480700 Catalog Number :

Device Description : Nemoto SONIC SHOT GX contrast delivery system for MRI applications.

Device Class : 2

Duns Number: 692691710

Premarket Exempt : No

Product Code : IZQ

Prescription Use : Yes

Device Count : 1

Rempress - 04560138481004 Catalog Number :

Device Description : Nemoto Rempress contrast delivery system for angiography, pedestal type unit.

Device Class :

Duns Number: 692691710

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

DUAL SHOT alpha 7 - 04560138481707 Catalog Number :

Device Description : Nemoto DUAL SHOT alpha 7 contrast delivery system for CT applications.

Device Class :

Duns Number: 692691710

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

PRESS DUO elite - 04560138482605 Catalog Number :

Device Description : Nemoto PRESS DUO elite dual-head angiographic contrast delivery system, separate Nemoto PRESS DUO elite dual-head angiographic contrast delivery system, separate type unit.

Device Class :

Duns Number: 692691710

Premarket Exempt : No

Product Code : DXT

Prescription Use : Yes

Device Count : 1

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