AVANOS* COOLIEF* Cooled Radiofrequency Kit Advanced - HSA Registration DE0510318
Access comprehensive regulatory information for AVANOS* COOLIEF* Cooled Radiofrequency Kit Advanced in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510318 and owned by Avanos Medical, Inc.. The device was registered on February 07, 2025.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The COOLIEF* Cooled Radiofrequency Kit Advanced and The COOLIEF* SINERGY* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the COOLIEF* Radiofrequency Generator (CRG-Advanced) to create lesions in nervous tissue. The device includes a fluid delivery system for commonly used fluid agents limited to contrast medium, saline, and/or anesthetic solution delivery at the target site. The COOLIEF* Cooled Radiofrequency Kit Advanced is also indicated for creating radiofrequency lesions of the genicular nerves for the management of moderate to severe knee pain of more than 6 months with conservative therapy, including medication, in patients with radiologically-confirmed osteoarthritis (grade 2-4) and a positive response (≥50% reduction in pain) to a diagnostic genicular nerve block.