BLACK EYE™ Endoscopic Marker
BLACK EYE™ is a sterile, non-pyrogenic ink designed to be used as an endoscopic marker for marking polyps and lesions in the gastrointestinal tract.
It is supplied syringe contain 5ml of the marker.
Ink is sterilized and ascetically packaged in the syringe, It is supplied sterile and disposable.
BLACK EYE™ is indicated for endoscopically marking lesion in the GI track when the endoscopist anticipates the lesion will require surgical removal within 30 days.
BLACK EYE™ is substantially equivalent to the predicate colon marker.
BLACK EYE™ and the predicate device have same indications for use.
Both are carbon black formulations that are used for endoscopically tattooing or marking the colon
Advantages of Black Eye™
Safe from Contamination
The use of India ink or methylene blue can be contaminated easily during the preparation or use of the injection solution.
As the Black Eye™ is supplied sterile and disposable, you can be safe from the danger of contamination of the patient.
The India ink for industrial use contains micro-organisms, heavy metals and dangerous chemicals like phenol, ammonia, etc.
The Black Eye™ is made of only safe and biocompatible materials which are passed through the cytotoxicity, sensitization and irritation tests by ISO 10993 standards.
As the methylene blue or Indocyanine green are dye, it is soluble in the body around a couple of days.
However the main materials of the Black Eye™ are insoluble pigments, they remain in the body as markings permanently.
Easy to use
It would be very complicated and irritating to use the India ink, methylene blue or Indocyanine etc.
The use of the Black Eye™ is just to take from the package and connect it to the injection needle.