SIRTEX MEDICAL PTY LTD

Address:Shop 6,St Leonards New South Wales,AU

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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

System, Applicator, Radionuclide, Manual (IWJ) (6) Holder, Syringe, Lead (IWR) (1) Shield, Protective, Personnel (KPY) (1) Shield, Vial (IWW) (1) System, Tomography, Computed, Emission (KPS) (1)

Premarket Exempt

No Yes

Clear

SIROS Delivery Dome - 00850014612009 Catalog Number : SIR-10100

Device Description : Delivery Dome for the administration of SIR-Spheres

Device Class : 1

Duns Number: 755092467

Premarket Exempt : Yes

Product Code : IWJ

Prescription Use : Yes

Device Count : 1

SIROS D-Vial Prep Set - 00850014612016 Catalog Number : SIR-10200

Device Description : Set for the preparation of SIR-Spheres

Device Class : 1

Duns Number: 755092467

Premarket Exempt : Yes

Product Code : IWJ

Prescription Use : Yes

Device Count : 1

SIROS Delivery Set - 00850014612023 Catalog Number : SIR-10300

Device Description : Sterile disposable tubing designed to provide proper routing of SIR-Spheres

Device Class : 1

Duns Number: 755092467

Premarket Exempt : Yes

Product Code : IWJ

Prescription Use : Yes

Device Count : 1

SIR-Spheres Delivery Apparatus - 00850014612047 Catalog Number :

Device Description : Delivery Apparatus for the administration of SIR-Spheres

Device Class : 1

Duns Number: 755092467

Premarket Exempt : Yes

Product Code : KPY

Prescription Use : Yes

Device Count : 1

SIR-Spheres Delivery Set - 00850014612054 Catalog Number :

Device Description : Sir-Spheres delivery set

Device Class : 1

Duns Number: 755092467

Premarket Exempt : Yes

Product Code : IWJ

Prescription Use : Yes

Device Count : 1

SIR-Spheres V-Vial - 00850014612061 Catalog Number :

Device Description : SIR-Spheres V-Vial

Device Class : 1

Duns Number: 755092467

Premarket Exempt : Yes

Product Code : IWJ

Prescription Use : Yes

Device Count : 1

SIR-Spheres V-Vial Holder - 00850014612078 Catalog Number :

Device Description : SIR-Spheres V-Vial Holder

Device Class : 1

Duns Number: 755092467

Premarket Exempt : Yes

Product Code : IWW

Prescription Use : Yes

Device Count : 1

SIR-Spheres Syringe Shield - 00850014612085 Catalog Number :

Device Description : SIR-Spheres Syringe Shield

Device Class : 1

Duns Number: 755092467

Premarket Exempt : Yes

Product Code : IWR

Prescription Use : Yes

Device Count : 1

SIR-Spheres Accessories Pack - 00850014612092 Catalog Number :

Device Description : Accessories Kit (consists of 1 delivery set, 1 v-vial and 1 v-vial holder)

Device Class : 1

Duns Number: 755092467

Premarket Exempt : Yes

Product Code : IWJ

Prescription Use : Yes

Device Count : 1

SIR-Spheres® Microspheres Activity Calculator (SMAC) - 00850014612108 Catalog Number :

Device Description : Dose activity calculator for Selective Internal Radiation Therapy (SIRT)

Device Class : 2

Duns Number: 755092467

Premarket Exempt : No

Product Code : KPS

Prescription Use : Yes

Device Count : 1

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