CIRRUS HEALTHCARE PRODUCTS LLC

Cirrus Healthcare Products LLC specializes in earplugs, producing both reusable and single-use models. These devices are designed primarily for noise protection in occupational, recreational, or general settings to safeguard hearing. The company’s portfolio includes products like the Leader and Up & Up series, all of which fall under the category of hearing protection.

Cirrus Healthcare Products LLC is headquartered in the United States. The company’s location is relevant for regulatory compliance and distribution, as it operates within the U.S. healthcare and industrial safety markets.

The devices produced by Cirrus Healthcare Products LLC are classified as Class II (U) under regulatory frameworks. This classification is typically assigned to devices with moderate risk, requiring special controls to ensure safety and effectiveness. The ‘U’ designation indicates they are listed in the FDA’s Unique Device Identifier (UDI) system, which helps track and manage these products in the healthcare supply chain.

Yes, the devices manufactured by Cirrus Healthcare Products LLC are included in the FDA’s Unique Device Identifier (UDI) database. This registry is used to maintain transparency and traceability of medical devices, ensuring that authorized products can be easily identified and verified by healthcare providers, distributors, and regulatory bodies.