The Standard is pleased to announce a change in direction for use of TS-205 Black Eye™ Endoscopic Marker. Since its first release in 2013, the customers have been asked to shake the syringe according to the direction for use on syringe labels and the Instruction for use.
Previous versions of Black Eye™ have a syringe label with the words “Shake well before use” and the Instruction for use have the words “Shake the syringe well when the pigment is not suspended properly.” Thanks to our proprietary technology, the two old phrases have been removed from Black Eye™.
The reason for this change is that no layer separation was found during long-term storage. The key is The Standard’s proprietary technology that coats carbon black with glycerin and distributes it well in Black eye™. The predicate devices ask the customers to shake the syringes vigorously before use as poor suspension can cause unstable marks by separating the solution.
Black Eye™ is the only endoscopic marker in the market with no pre-shake formula. In other words, Black Eye™ is much easier to use than the predicates since it saves time and effort for physicians and nurses to prepare the endoscopic procedure. The Standard will continue to make efforts to provide the best value products to the customers.