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510(k) Data Aggregation

    K Number
    K190864
    Device Name
    Konix Anti-Fog Solution
    Manufacturer
    Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler
    Date Cleared
    2020-08-27

    (512 days)

    Product Code
    OCT
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KONIX Anti-Fog solution is a sterile, disposable, functional, anti-fog solution. The antifog solution is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens. KONIX Antifog Solution is used to prevent the lenses of the imaging device from fogging due to the difference in body temperature before and during endoscopic and laparoscopic procedures.
    Device Description
    Konix Anti-Fog Solution is a single-use, sterile, and biocompatible laparoscopic accessory device. The product is released to the market as sterile and disposable with one polyurethane foam pad in a 6 ml polyethylene bottle. Secondary packaging is composed of PET film and Medical Kraft Sealing Paper. Konix Anti-Fog Solution is intended to be used to prevent the lenses of the imaging device from fogging due to the difference in body temperature before and during endoscopic and laparoscopic procedures. The mechanism of defogging or anti-fogging action of Konix Anti-Fog Solution, works by physically changing the water droplets that form on the lens surface from round droplets, to a flat transparent sheet of water, a phenomenon known as 'wetting'.
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    K Number
    K140506
    Device Name
    JOY DROPS (TM) NATURAL PERSONAL LUBRICANT GEL
    Manufacturer
    TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA
    Date Cleared
    2015-04-17

    (414 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    JoyDrops® Natural Personal Lubricant Gel is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
    Device Description
    JoyDrops® Natural Personal Lubricant Gel is a water-based personal lubricant gel that is contained in a 3.38 fluid ounces (100 mL) polymer container with a pump dispenser.
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    K Number
    K130581
    Device Name
    KONIX STERILE GEL
    Manufacturer
    TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA
    Date Cleared
    2014-06-18

    (470 days)

    Product Code
    MUI, REG
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    As stated on Label: Contact medium for ultrasonic and electrical transmission gel. Konix® Sterile Gel is sterilized by gamma irradiation and intended for use in all diagnostic ultrasound procedures that currently use an ultrasound coupling gel or other fluid, alone or in combination with a transducer cover, where sterlility and in vivo biocompatibility are required. It can be used on the skin where the risk for infections is especially high, especially with oven tissue Doppler applications; and can be used for cystoscopic and ultrasound examinations. Konix® Serile Gel can be used on the skin or in open tissue where there is a risk for infections, such as in open tissue Doppler applications. It can be used during surgery; for cystoscopic and vaginal ultrasound and Doppler examinations; for cardiac surgery and ultrasound procedures; and as a lubricant in biopsy applications
    Device Description
    Konix® Sterile Gel is an in vivo biocompatible sterile couplant intended for use as a scanning gel in surgical procedures, biopsies and similar sterile applications. It is used to couple sound waves between the patient and medical imaging electronic transducers during intraoperative and intracavitary medical diagnostic ultrasound imaging procedures such as transcutaneous ultrasound image guided biopsy and aspiration, doppler examinations of organ and tissue intraoperative ultrasound imaging, intra-cavity ultrasound imaging, and gel infusion sonography. Major characteristics include: - No toxic effects; produced as a completely harmiess material . - Hypoallergenic; non-irritating; no cytotoxicity . - Water soluble, non-staining and easily cleanable - Does not contain any lipid components . - Free from formaldehyde and salt . - Odorless . - Gamma radiated to assure sterility . - Will not damage the probe . - Does not contain air bubbles . - pH = 7 .
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    K Number
    K101952
    Device Name
    KONIX ULTRASOUND GEL
    Manufacturer
    TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA
    Date Cleared
    2011-05-27

    (319 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Konix® Ultrasound Gel is intended for general use as a nonsterile transmission media for acoustically coupling a transducer to a human body surface during external, diagnostic ultrasound imaging procedures. It is placed on the patient's skin prior to initiating an ultrasound examination. It is indicated for prescription use only.
    Device Description
    Konix® Ultrasound Gel consists of deionized water, carbomer, triethanolamine, monopropylene glycol, 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3 one and is a type of conductive medium, i.e., scanning gel, used in ultrasound diagnostic techniques. A scanning gel acts as a couplant that provides an acoustic pathway between the transducer and the skin. In addition, the gel eliminates air (a disruptive influence) from the interface and adapts the contours of the probe to the skin. The major characteristics of Konix® Ultrasound Gel include: - . Hypoallergenic, non-irritating - Water soluble, non-staining and easily cleanable . - Does not contain oil and fatty matter . - Free from formaldehyde and salt . - No toxic effects . - Produced as a completely harmless material . - No smell ◆ - Vacuum treated production . - Not-damageable to the probe . - . Does not contain air bubbles - pH level is 7 .
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