Black Eye™ is a sterile, non-pyrogenic, purified carbon formulation designed to be used as an endoscopic marker for marking polyps and other lesions in the gastrointestinal tract. Black Eye™ is supplied in a ready-to-use, pre-filled syringe containing 5ml of Black Eye™ marker, manufactured by The Standard Co. Ltd. (www.thestandard.co.kr). Shelf life is 2 years.
- Technological Characteristics and Substantial Equivalence: Black Eye™ is substantially equivalent to the predicate device and has the same indications for use: both are carbon black formulations that are used for endoscopically tattooing or marking the GI tract during an endoscopic procedure. The mark provides a lasting reference point for subsequent examination or removal of the tissue.
- The safe choice for your patients: India ink preparations contain unpredictable amounts of shellac, phenol, and ammonia that should be avoided. Black Eye™ is a biocompatible, non-toxic formulation which contains no India ink. Each Black Eye™ syringe is supplied with a handy patient record label documenting lot information for your patient’s record.
- The safe choice for your practice: Black Eye™ has been successfully used in over 45 countries world-wide with years of problem-free clinical experience. Black Eye™ is distributed in the U.S.A. by four experienced regional medical device distributors who specialize in endoscopic devices.
- Lower cost per use compared to other endoscopic markers.
Available in the USA May 1, 2019
TS-205 Black Eye ™ Endoscopic Marker, 5 ml sterile in prefilled syringe ready-for-use, supplied twelve (12) Black Eye™ syringes per canister.
SMD Wynne Corp. distributes Black Eye™ in the following states: IL, OH, IN, KY, WV, TN, WI, MN, SD, ND, IA, KS, MO, NE.
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