Surgical procedure kit, general-purpose, single-use, non-medicated

Intended purpose

The device consists of a collection of disposable, single use, hand held, non-active surgical instruments, dressing materials and components presented in a sterile pack. The device is intended to be used by health professionals to perform general purpose surgical procedures. Some of the surgical instruments included in the device are invasive devices intended for transient use in the oral cavity and do not contain any pharmaceuticals. All the components in the sterile pack are class IIa or class I medical devices.