OSPREY MEDICAL INC.

Address:5600 Rowland Rd Suite 250,Minnetonka,MN,55343,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) (10)

Premarket Exempt

Clear

DYETECT™ Contrast Monitoring Disposable Kit - 00815241020416 Catalog Number :

Device Description : DyeTect Contrast Monitoring Disposable Kit

Device Class : 2

Duns Number: 938215568

Premarket Exempt : No

Product Code : DXT

Prescription Use : No

Device Count : 1

DYETECT™ Contrast Monitoring Disposable Kit - 00815241020423 Catalog Number :

Device Description : DyeTect Contrast Monitoring Disposable Kit

Device Class : 2

Duns Number: 938215568

Premarket Exempt : No

Product Code : DXT

Prescription Use : No

Device Count : 1

DYETECT™ Contrast Monitoring Disposable Kit - 00815241020430 Catalog Number :

Device Description : DyeTect Contrast Monitoring Disposable Kit

Device Class : 2

Duns Number: 938215568

Premarket Exempt : No

Product Code : DXT

Prescription Use : No

Device Count : 1

DYETECT™ Contrast Monitoring Disposable Kit - 00815241020447 Catalog Number :

Device Description : DyeTect Contrast Monitoring Disposable Kit

Device Class : 2

Duns Number: 938215568

Premarket Exempt : No

Product Code : DXT

Prescription Use : No

Device Count : 1

DYETECT™ Contrast Monitoring Disposable Kit - 00815241020461 Catalog Number :

Device Description : DyeTect Contrast Monitoring Disposable Kit

Device Class : 2

Duns Number: 938215568

Premarket Exempt : No

Product Code : DXT

Prescription Use : No

Device Count : 1

DYEVERT™ PLUS - 00815241020478 Catalog Number :

Device Description : DyeVert Plus System Contrast Monitoring System

Device Class : 2

Duns Number: 938215568

Premarket Exempt : No

Product Code : DXT

Prescription Use : No

Device Count : 1

SMART SYRINGE - 00815241020485 Catalog Number :

Device Description : Smart Syringe to be used with DyeVert Plus or the CMSW Disposable Kit

Device Class : 2

Duns Number: 938215568

Premarket Exempt : No

Product Code : DXT

Prescription Use : No

Device Count : 1

SMART SYRINGE - 00815241020492 Catalog Number :

Device Description : Smart Syringe to be used with DyeVert Plus or the CMSW Disposable Kit

Device Class : 2

Duns Number: 938215568

Premarket Exempt : No

Product Code : DXT

Prescription Use : No

Device Count : 1

SMART SYRINGE - 00815241020508 Catalog Number :

Device Description : Smart Syringe to be used with DyeVert Plus or the DyeTect Disposable Kit

Device Class : 2

Duns Number: 938215568

Premarket Exempt : No

Product Code : DXT

Prescription Use : No

Device Count : 1

SMART SYRINGE - 00815241020515 Catalog Number :

Device Description : Smart Syringe to be used with DyeVert Plus or the CMSW Disposable Kit

Device Class : 2

Duns Number: 938215568

Premarket Exempt : No

Product Code : DXT

Prescription Use : No

Device Count : 1

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