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510(k) Data Aggregation

    K Number
    K211691
    Device Name
    Ultrast Gel
    Manufacturer
    Ultrast, Inc.
    Date Cleared
    2021-12-22

    (203 days)

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

    Ultrast, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ultrast Gel is an in vivo biocompatible sterile sterile couplant intended for use as a scanning gel in surgical procedures, biopsies and similar sterile applications. Ultrast Gel is used to couple sound waves between the patient and medical imaging electronic transducers during intracavitary medical diagnostic ultraging procedures, transcutaneous ultrasound image guided biopsy and aspiration, intracavity ultrasound imaging, and gel infusion sonography. Ultrast Gel is unit dose packaged, sterilized 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 sterility, in vivo biocompatibility and bioelimination are required. ULTRAST Gel is available by prescription only for use by healthcare providers trained in performing the indicated procedure.
    Device Description
    The Ultrast Gel device, manufactured for Ultrast, Inc. is a phase changing hydrogel ultrasound coupling agent comprised of hydroxy-propylcellulose, sodium chloride, sodium citrate, and water. HCl may be added to adjust pH if necessary. The gel is viscous at room temperature, but subsequently liquefies as its temperature rises and reaches body temperature. In addition to general lubricating/coupling properties, the gel may be instilled in the uterine cavity through a standard intrauterine insemination (IUI) catheter to provide excellent ultrasonographic visualizations, after which point it liquifies and passes out of the uterine cavity. The gel is contained in a single use 5cc capped syringe enclosed in a peel pouch to maintain sterility.
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