Pramand, LLC

Pramand, LLC specializes in dural sealants, which are medical devices designed to help with wound healing and prevent cerebrospinal fluid leakage during surgeries. Their primary focus is on products like the SpineSeal Spine Sealant for spinal applications and the CraniSeal Dural Sealant for cranial procedures, both used in neurosurgical and orthopedic interventions.

Pramand, LLC is based in the United States, where its dural sealants are developed and distributed. The company’s headquarters and operations are located within the country, ensuring compliance with US regulatory standards for medical devices.

Pramand, LLC’s devices are listed in the FDA’s Premarket Approval (PMA) and Unique Device Identification (UDI) databases. These registries help track and identify the company’s dural sealants, ensuring transparency and compliance with US medical device regulations.

Pramand, LLC’s dural sealants are classified as Class III medical devices under US regulations. This classification is typically assigned to devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury. The classification reflects the critical role these sealants play in neurosurgical and orthopedic procedures.