PACKAGE INSERT:
Description
OSTENE™ is a water-soluble surgical implant material and it provides for control of bleeding from bone surfaces by acting as a mechanical barrier. OSTENE™ is a sterile mixture of water-soluble alkylene oxide copolymers, derived from ethylene oxide and propylene oxide.
Indications
OSTENE™ is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces. OSTENE™ should be warmed to desired consistency using aseptic technique.
Actions
OSTENE™ achieves local hemostasis of bone by acting as a mechanical barrier. It does not act biochemically.
Contraindications
1. Sites with active or latent infections.
2. The use of the product to lend structural support to bone.
Warnings and Precautions
1. OSTENE™ is provided sterile for single use only. DO NOT RESTERILIZE. Discard any open, unused, or damaged packages. DO NOT USE if there is a loss of sterility of the device.
2. OSTENE™ should not be subjected to excess heat. Store at room temperature away from direct heat, including sunlight.
Instructions for Use
OSTENE™ works best at body temperature and should be warmed to desired consistency using aseptic technique. The unopened foil packet may be immersed into a warm sterile solution and the material may by manipulated with dry gloved fingers. The unopened packet may also be placed in a warming cabinet at temperatures at or below 43°C (110°F). OSTENE™ handles more like a gum than a wax. For use in the control of bone bleeding, OSTENE™ may be pressed into bleeding bone and may be worked across the bleeding surface as indicated by the surgical circumstances and the preference of the surgeon.
Sterility
OSTENE™ is sterilized using electron beam irradiation. Removal from the sterile package using aseptic techniques should only take place immediately before use. OSTENE™ MUST NOT BE RESTERILIZED BY ANY METHOD.
Warranty
All products are warranted to be free from defects in material and workmanship. No warranty is made for any purpose other than in the product specifications and labeling.
Caution
Federal law (USA) restricts this device to sale by or on the order of a physician.
Additional information pertaining to specific devices or issues may be obtained from Ceremed, Inc.
©2008 CF712A0708
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