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Silicone Stoma Button 

Description 
 
Silicone Stoma Buttons are a self-retaining device, moulded from silicone elastomer which is biocompatible, and latex and phthalate-free. They are soft and durable, with all edges radiused and the outer surface entirely smooth, to enhance patient comfort and tolerance. Stoma Buttons are discrete, passive, friction-fit devices that do not require an external tie or strap, and only the narrow outer flange is visible when the device is in situ. The device contains Barium Sulphate (BaSO4) which may aid visibility under X-ray. Available in three sizes. 
Intended Use: 
 
Medasil Silicone Stoma Buttons are intended to be used for temporary non-surgical maintenance of tracheostomas in the adult patient population. Each device is intended to be used up to 29 days. The device is supplied non-sterile, for single patient use. 
Indications for Use 
 
Indications include, but are not limited to: 
 
For maintaining patency of the tracheostoma following laryngectomy. 
For patients who need to continuously keep their tracheostoma open (long-term tracheal access) and who no longer require a tracheostomy tube or no longer reliant on positive ventilation or the mechanical support afforded by a full-length-tube. 
For patients who may require repeated tracheostomies, such as those who have myasthenia gravis, spinal cord injuries or sleep apnoea. 
For patients undergoing rehabilitation while working towards de-cannulation, or in patients for whom a future surgery is planned. 
 
 
 
 
 
 
CODE 
DIAMETER 
FLANGE OPTIONS 
130-1010-1710 
10MM (0.39") 
STANDARD FLANGE 1.75MM (0.06”) 
130-1010-1712 
12MM (0.47") 
STANDARD FLANGE 1.75MM (0.06”) 
130-1010-1714 
14MM (0.55") 
STANDARD FLANGE 1.75MM (0.06”)