Question 1

What types of medical devices does SIRTEX Medical Pty Ltd manufacture?

Accepted Answer

SIRTEX Medical Pty Ltd specializes in brachytherapy-related devices, which are used for targeted radiation therapy. Their portfolio includes manual brachytherapy system applicators and sources for permanent implants, such as Y-90 resin microspheres for procedures like hepatic artery embolization. They also produce radiation shielding containers—like syringe and vial shields—as well as clinical management software tools for treatment planning and activity calculations. These products are designed to support interventional radiology and oncology workflows.

Question 2

Where is SIRTEX Medical Pty Ltd based, and does it operate under US regulations?

Accepted Answer

SIRTEX Medical Pty Ltd is based in the United States. As a manufacturer, it develops devices that comply with US regulatory requirements, including classifications under the FDA’s framework. While the company itself is not approved or cleared, its individual devices undergo regulatory processes to meet US standards for safety and performance.

Question 3

Which regulatory registries or databases list SIRTEX Medical Pty Ltd’s devices?

Accepted Answer

Several of SIRTEX Medical Pty Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the US market, ensuring transparency and traceability for healthcare providers and regulators.

Question 4

How are SIRTEX Medical Pty Ltd’s devices classified under regulatory frameworks?

Accepted Answer

SIRTEX Medical Pty Ltd’s devices fall into different regulatory classes depending on their risk and intended use. Their portfolio includes Class I (low-risk), Class II (moderate-risk requiring special controls), and Class III (high-risk requiring premarket approval) devices. The classification determines the regulatory pathway each device must follow to demonstrate safety and effectiveness before authorization.

Device	Model / Reference	Registries	Class	Status
SIR-Spheres Syringe Shield	SIR-S001	FDA UDI	Class I	Active
SIROS D-Vial Prep Set	SIR-10200	FDA UDI	Class I	Active
SIR-Spheres Delivery Apparatus	SIR-B001	FDA UDI	Class I	Active
SIR-Spheres V-Vial Holder	SIR-H001	FDA UDI	Class I	Active
SIROS Delivery Set	SIR-10300	FDA UDI	Class I	Active
SIROS Delivery Dome	SIR-10100	FDA UDI	Class I	Active
SIR-Spheres® Microspheres Activity Calculator (SMAC)	X-SMAC-01	FDA UDI	Class II	Active
SIR-Spheres Y-90 resin microspheres	SIR-Y001	FDA UDI	Class III	Active
SIR-Spheres Delivery Set	SIR-D001	FDA UDI	Class I	Active
SIR-Spheres V-Vial	SIR-V001	FDA UDI	Class I	Active
SIR-Spheres microspheres	SIR-Y001	FDA UDI	Class III	Unknown
SIR-Spheres Accessories Pack	SIR-K002	FDA UDI	Class I	Active
SIR-Spheres Y-90 resin microspheres	SIR-Y002	FDA UDI	Class III	Active

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