Linacol Medical

Each box (secondary packaging) contains product in 1 double sterile bag and one ampoule. Secondary packaging contains product name, manufacturer information and 1 label attached to it.

The packaging of Radiopaque Bone Cement contains two sterile components. One of these components is an ampoule containing 10 ml or 20 ml of colorless liquid monomer.

The other component is 20g or 40g of a composition of fine powder PMMA, BPO as an initiator, a radiopacifying agent and a packing.

Barium sulfate added to Radiopaque Bone Cement acts as a contrast agent for X-ray examination.

During use, powder and liquid are mixed. This mixture is designed to lead to the exothermic polymeric formation of a soft, flexible, dough-like mass. As the reaction progresses, a hard, cement-like composition forms within a few minutes.

Bone cement is obtained by mixing the liquid and powder part during the surgical operation by the orthopedic and traumatology specialist.

The powder part of the product was validated ETO, the liquid part was sterilized by aseptic filling method, and ETO sterilization was used after both components were taken into the secondary box. The product is a disposable product that is not suitable for re-sterilization and use, and does not need to be sterilized/re-sterilized by the user.