RADUX DEVICES, LLC

Address:11292 86th Ave N Suite 101,Maple Grove,MN,55369,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

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (DTL) (3) Screen, Leaded, Operator Radiation Protector (EAK) (1)

Premarket Exempt

Yes

Clear

StandTall - 00853714008004 Catalog Number : ST0010L

Device Description : Sheath Extender and Securement Clasp, 10cm

Device Class :

Duns Number: 079668796

Premarket Exempt : Yes

Product Code : DTL

Prescription Use : Yes

Device Count : 1

StandTall - 00853714008011 Catalog Number : ST0025L

Device Description : Sheath Extender and Securement Clasp, 25cm

Device Class : 2

Duns Number: 079668796

Premarket Exempt : Yes

Product Code : DTL

Prescription Use : Yes

Device Count : 1

StandTall - 00853714008028 Catalog Number : ST0015L

Device Description : Sheath Extender and Securement Clasp, 15cm

Device Class : 2

Duns Number: 079668796

Premarket Exempt : Yes

Product Code : DTL

Prescription Use : Yes

Device Count : 1

Steradian Shield - 00853714008035 Catalog Number : SS0100

Device Description : Radiation Protection Shield

Device Class : 1

Duns Number: 079668796

Premarket Exempt : Yes

Product Code : EAK

Prescription Use : Yes

Device Count : 1

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