NORTHSTAR MEDICAL RADIOISOTOPES, LLC

NorthStar Medical Radioisotopes, LLC specializes in fixed radiation shielding panels. These devices are engineered to protect healthcare personnel and equipment from ionizing radiation exposure during procedures involving radioactive materials. Examples include the Lower BayShield and ExoShield, which are designed for use in clinical settings where radiation safety is critical.

NorthStar Medical Radioisotopes, LLC is based in the United States. While the company’s location influences its regulatory framework, individual devices—such as their radiation shielding panels—must undergo their own authorization process to comply with applicable regulations. The U.S. FDA’s Unique Device Identifier (UDI) database includes their listed devices, which helps ensure traceability and regulatory transparency.

NorthStar Medical Radioisotopes, LLC’s radiation shielding panels are classified as Class I devices under FDA regulations. This classification is typically assigned to devices posing minimal risk to users, as determined by the FDA’s risk-based categorization system. Class I devices often require less stringent premarket review, though compliance with good manufacturing practices and other regulatory requirements still applies.

NorthStar Medical Radioisotopes, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to medical devices, enabling better tracking, transparency, and compliance verification. This registry helps healthcare providers, regulators, and other stakeholders confirm the legitimacy and traceability of the company’s radiation shielding panels.