COAGCO LLC

COAGCO LLC specializes in intranasal splints, specifically non-biodegradable devices designed for nasal packing. Their primary product, the Coag it NASAL PACK, is intended for temporary nasal airway support or hemorrhage control in clinical environments. These devices are engineered to provide short-term stability or pressure control within the nasal cavity.

COAGCO LLC is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA’s Unique Device Identifier (UDI) database includes COAGCO’s products, which helps ensure traceability and compliance tracking for Class I devices—those deemed to pose minimal risk and typically requiring less stringent premarket review.

COAGCO LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product code to each device, enabling better tracking, transparency, and compliance monitoring. This registry is critical for healthcare providers, regulators, and manufacturers to verify device details and ensure proper use.

COAGCO LLC’s devices, such as the Coag it NASAL PACK, are classified as Class I under FDA regulations. Class I devices are generally considered low-risk and often involve simple mechanical or electrical devices with minimal potential harm. Due to this classification, they typically undergo less stringent premarket review, though they must still comply with general controls and may require registration and listing with the FDA.