Black Eye™ Endoscopic Marker
- Black Eye™ is a sterile, non-pyrogenic, purified carbon formulation designed to be used as a permanent 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. Thanks to proprietary technology, Black Eye™ leaves a permanent mark, providing a “Lifetime of Surveillance.”
- 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.
- Best Value: Black Eye™ offers lower cost per use when compared to other endoscopic markers.
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: IA, IL, IN, KS, KY, MN, MO, ND, NE, OH, SD, TN, WI, WV
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