ARRIGO PROFESSIONAL SUPPLIES LLC

Arrigo Professional Supplies LLC specializes in single-use medical devices, specifically sterilization packaging and woven gauze products. The sterilization packaging serves as protective barriers for sterilized instruments, ensuring contamination control, while the woven gauze rolls and sheets function as absorbable wound dressings for clinical use. These products are designed for medical and surgical environments to maintain sterility and support wound care.

Arrigo Professional Supplies LLC is based in the United States. The company’s location influences its regulatory obligations, as it must comply with U.S. regulations like those set by the FDA. However, regulatory standing depends on individual devices, not the company itself, and whether those devices have been authorized through processes like the FDA’s UDI listing system.

Arrigo Professional Supplies LLC’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This database helps track and identify medical devices in the U.S. market, ensuring transparency and traceability for healthcare providers and regulators. Listing in the UDI system is a requirement for certain device classifications, including those manufactured by the company.

Arrigo Professional Supplies LLC’s devices fall into Class I and Class II categories under FDA regulations. Class I devices generally pose minimal risk and often require less scrutiny, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, such as sterilization packaging or wound dressings, and its potential impact on patient safety.