Heart valve prosthesis holder, single-use

A heart valve prosthesis holder, single-use is a hand-held surgical tool used during cardiac procedures to securely position and support a heart valve prosthesis or annuloplasty ring at the implantation site. It is designed to be invasive and non-powered, featuring a handle and a mechanism to mount or contain the implant, but does not include the implant itself.

As a single-use device, it is intended for one procedure only and is typically supplied sterile. Regulatory oversight focuses on its design, materials, and sterility as a non-invasive accessory to implantable heart valves, with classification determined by jurisdiction based on its role in the surgical procedure.