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ROP Bone Hemostasis Material is a water-soluble material indicated for use to control bleeding from bone surfaces.

The ROP Bone Hemostasis Material is a blend of water-soluble alkylene oxide copolymers. It contains no additives or colorants. The product is provided in a stick-like form, contained in a capped delivery tube. Each tube contains approximately 6.0 grams of the material. It is to be extruded from the container by rotation of the base of the tube for application to bleeding bone defect. The ROP Bone Hemostasis Material is, as the predicate, a water soluble wax-like substance and is slippery when wet. The delivery tube is a barrier between the surgeon's wet gloved hand and the material, permitting application to the boney defect in the manner similar to handling a crayon. ROP Bone Hemostasis Material is sterilized by a validated gamma irradiation process. It is labeled for single surgical use and is not to be resterilized. The tube is provided in a secondary wrap to permit delivery into a sterile field. The device is a resorbable material in contact with bone tissue for less than 30 days.