ONE DEGREE MEDICAL HOLDINGS, LLC

ONE DEGREE MEDICAL HOLDINGS, LLC specializes in single-use medical devices primarily for operating rooms and procedural settings. Their portfolio includes medical equipment/instrument drapes (disposable protective covers), surgical fluid heating plates (to maintain sterile fluid temperatures), and bowl/basin stands (adjustable supports for surgical basins and instruments). These products are designed for convenience, sterility, and efficiency in clinical environments.

The company is based in the United States, which means its devices must comply with FDA regulations. Since the products fall under Class I and Class II classifications, they are subject to FDA oversight, including mandatory listing in the FDA’s Unique Device Identification (UDI) system. This ensures traceability and transparency in the medical device supply chain.

Yes, all of ONE DEGREE MEDICAL HOLDINGS, LLC’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry is critical for healthcare providers, regulators, and supply chain partners because it allows for accurate tracking, recall management, and compliance verification of medical devices. The UDI system ensures that each device can be uniquely identified throughout its lifecycle.

ONE DEGREE MEDICAL HOLDINGS, LLC’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls (like good manufacturing practices) for safety and effectiveness. Class II devices involve a higher risk and may require additional controls, such as performance standards or post-market surveillance. The classification determines the regulatory pathway and oversight required for each product.