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510(k) Data Aggregation
K Number
K190864Device 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
876.1500Why 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
K140506Device 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
884.5300Why 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
K130581Device Name
KONIX STERILE GEL
Manufacturer
TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA
Date Cleared
2014-06-18
(470 days)
Product Code
MUI, REG
Regulation Number
892.1570Why 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
K101952Device Name
KONIX ULTRASOUND GEL
Manufacturer
TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA
Date Cleared
2011-05-27
(319 days)
Product Code
ITX
Regulation Number
892.1570Why 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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