Spsmedical Supply Corp.

Spsmedical Supply Corp. specializes in sterilization-related products, including chemical and biological indicators for monitoring sterilization processes. Their devices track the effectiveness of sterilization methods like steam, ethylene oxide (EO), and dry heat. They also produce single-use sterilization packaging, such as disposable wraps, and biological monitoring services like mail-in systems and culture kits. These products ensure medical devices are safely sterilized before use.

Spsmedical Supply Corp. is based in the United States, which means its devices fall under FDA jurisdiction. Since the company’s products are classified as Class II devices, they are subject to FDA’s 510(k) premarket notification process and must comply with UDI (Unique Device Identifier) requirements. The FDA registers these devices in its 510(k) and UDI databases to track compliance and market performance.

Spsmedical Supply Corp.’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) process ensures that each device meets FDA safety and effectiveness standards before entering the market, while the UDI system provides a unique identifier for tracking devices throughout their lifecycle. These registries help regulators and healthcare providers verify compliance and traceability of sterilization-related products.

Spsmedical Supply Corp.’s devices are classified as FDA Class II, which means they pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. This classification requires manufacturers to submit a 510(k) premarket submission to demonstrate their devices meet regulatory requirements. For users, this classification indicates that these sterilization indicators and packaging have undergone evaluation to help ensure reliable performance in medical sterilization processes.