BLACK EYETM ENDOSCOPIC MARKER

BLACK EYETM 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 EYETM is indicated for endoscopically marking lesion in the GI track when the endoscopist anticipates the lesion will require surgical removal within 30 days.

BLACK EYETM is substantially equivalent to the predicate colon marker.
The BLACK EYETM and the predicate device have same indications for use.
Both are carbon black formulations that are used for endoscopically tattoing or marking the colon.

Advantages of Black EyeTM
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 EyeTM is supplied sterile and disposable, you can be safe from the danger of contamination of the patient.

Biocompatible
The India ink for industrial use contains micro-organisms, heavy metals and dangerous chemicals like phenol, ammonia, etc.
The Black EyeTM is made of only safe and biocompatible materials which are passed through the cytotoxicity, sensitization and irritation tests by ISO 10993 standards.

Clear Identification
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 EyeTM 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 EyeTM is just to take from the package and connect it to the injection needle.