ISORAY MEDICAL, INC.

ISORAY MEDICAL, INC.

Address:350 Hills St Ste 106,RICHLAND,WA,99354,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

Source, Brachytherapy, Radionuclide (KXK) (6) System, Applicator, Radionuclide, Manual (IWJ) (4)

Premarket Exempt

No Yes

Clear

GliaSite® Catheter Tray - M74810200 Catalog Number :

Device Class : 2

Duns Number: 113577485

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

GliaSite® Catheter Tray - M74810300 Catalog Number :

Device Class : 2

Duns Number: 113577485

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

GliaSite® Catheter Tray - M74810400 Catalog Number :

Device Class : 2

Duns Number: 113577485

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

Iotrex® - M74881500 Catalog Number :

Device Class : 2

Duns Number: 113577485

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

Cesitrex™ - M74881600 Catalog Number :

Device Class : 2

Duns Number: 113577485

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

GliaSite® Access Tray - M74890050 Catalog Number :

Device Class : 2

Duns Number: 113577485

Premarket Exempt : No

Product Code : KXK

Prescription Use : Yes

Device Count : 1

Blu Blade - M748BB10 Catalog Number :

Device Class : 1

Duns Number: 113577485

Premarket Exempt : Yes

Product Code : IWJ

Prescription Use : No

Device Count : 1

Blu Build Spacer Cartridge - M748BBC10 Catalog Number :

Device Class : 1

Duns Number: 113577485

Premarket Exempt : Yes

Product Code : IWJ

Prescription Use : No

Device Count : 1

Blu Build Real Time Loader Device - M748BBL10 Catalog Number :

Device Class : 1

Duns Number: 113577485

Premarket Exempt : Yes

Product Code : IWJ

Prescription Use : No

Device Count : 1

Blu Build Sleeve Carrier - M748BBS10 Catalog Number :

Device Class : 1

Duns Number: 113577485

Premarket Exempt : Yes

Product Code : IWJ

Prescription Use : No

Device Count : 1

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