Profile: Certol International, LLC specializes in providing sterilization and disinfection products, which are used in hospitals and clinical settings. Our product area includes proEZfoam, proview plus pouches, proclense plus, prowash, prospray wipes, excelle and procheck S. Our ProEZ foam™ is a four enzyme spray formulated to start the cleaning process on soiled instruments and prevents soils from drying on instruments. Our proEZ foam offers robust anti-corrosive system. It never dries hard or sticky. Our Excelle® is an antiseptic skin cleanser with chlorohexidine gluconate solution. It binds to skin protein for persistence of action. Our dental products include pathex, proE-vac, v-cide and pro tray disposable trays. Our Pathex™ is a disinfectant/cleaner and holding solution.
FDA Registration Number: 1720499
11 Products/Services (Click for related suppliers)
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| • Disposable Impression Trays |
| • Medical Device, Sterilant (FDA Code: MED / 880.6885) A liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin. |
| • Medical Devices, Disinfectant (FDA Code: LRJ / 880.6890) A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. A general purpose disinfectant can be used to preclean or decontaminate critical or semicritical medical devices prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin. |
| • Physical/Chemical Sterilization Process Indicator (FDA Code: JOJ / 880.2800) A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. |
| • Protective Barrier Cover (FDA Code: MMP / 878.4370) A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy. |
| • Single Lumen Hypodermic Needle (FDA Code: FMI / 880.5570) A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set. |
| • Sterilization Indicators (FDA Code: LRT / 880.2800) |
| • Sterilization Wrap (FDA Code: FRG / 880.6850) A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. |
| • Sterilization Wrap Containers (FDA Code: KCT / 880.6850) |
| • Surgical Mask for Nurses |
| • Surgical Masks (FDA Code: FXX / 878.4040) Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded. |