Pemax Kunststoff GmbH

Pemax Kunststoff GmbH specializes in single-use sterile medical equipment drapes and covers. Their portfolio includes items like sterile drapes for remote control units, C-arm systems, and robotic scopes, as well as lens protective caps for medical devices. Additionally, they produce disposable button cannulas specifically designed for wound irrigation, available in lengths of 45 mm, 70 mm, and 100 mm. These products are intended to maintain sterility and hygiene in medical procedures.

Pemax Kunststoff GmbH operates from the United States. The company’s location is relevant for regulatory compliance, supply chain logistics, and customer support, particularly for medical device manufacturers and healthcare providers in North America.

Pemax Kunststoff GmbH’s devices are listed in the FDA Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and other stakeholders to verify product details, such as manufacturer information, device classifications, and compliance data.

Pemax Kunststoff GmbH’s devices fall under FDA’s Class I and Class II regulatory categories. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with, as outlined in FDA guidelines.

The primary purpose of Pemax Kunststoff GmbH’s single-use sterile drapes and covers is to maintain a sterile field during medical procedures. These products are designed to protect equipment like remote control units, C-arm systems, and robotic scopes from contamination, reducing the risk of infection and ensuring patient safety. Their disposable nature also minimizes the need for reprocessing, streamlining workflows in clinical settings.