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510(k) Data Aggregation

    K Number
    K133554
    Device Name
    SURGICAL LIGHT HANDLE COVER
    Manufacturer
    MICROTEK MEDICAL, INC. AN ECOLAB COMPANY
    Date Cleared
    2014-04-08

    (140 days)

    Product Code
    FTA
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROTEK MEDICAL, INC. AN ECOLAB COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A device intended to be used as a disposable barrier for a surgical lighting system and which allows a surgical team member to manually adjust the lighting system. This is a single-use device
    Device Description
    The Surgical Light Handle Cover is a polycarbonate injection molded device shaped to fit a surgical light that has release buttons protruding from the surgical light handle. The Surgical Light Handle Cover has apertures located at the end of the device, proximal to the surgical light, which correspond to the release buttons on the surgical light handle. When the Surgical Light Handle Cover is attached to the light, the release buttons will interface with the apertures to secure the Surgical Light Handle Cover to the light handle. The Surgical Light Handle Cover is hollow in the center, with transparent polycarbonate located near the distal end. The transparent end permits the use of a recording device, which may be mounted onto the surgical light. The transparent end allows light to pass through for the purpose of recording images, it does not provide image enhancement or magnification.
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    K Number
    K110358
    Device Name
    VENODYNE V810
    Manufacturer
    MICROTEK MEDICAL, INC.
    Date Cleared
    2011-05-05

    (87 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROTEK MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Venodyne DVT Advantage 810 is designed to compress the lower limbs aiding the blood flow back toward the heart to prevent DVT (Deep Veep Thrombosis) in patients at risk.
    Device Description
    The Venodyne DVT Advantage 810 compression system is a microprocessor controlled pneumatic pump that inflates and deflates a set of single chamber leg garments (sleeves) or foot garments (sleeves), which are placed on the patient's lower limbs or feet. During the inflation cycle, the inflatable garments compress the limb or foot along with the veins contained within to a preset pressure. This assists in propelling blood from the lower limbs or feet towards the heart. During the deflation cycle, the veins are allowed to fill with blood. The cycle is repeated intermittently.
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    K Number
    K102971
    Device Name
    FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK
    Manufacturer
    MICROTEK MEDICAL, INC.
    Date Cleared
    2011-02-23

    (140 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROTEK MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Freedomaire III Surgical Helmet System is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel in order to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
    Device Description
    Not Found
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    K Number
    K062899
    Device Name
    MICROTEK MEDICAL SURGICAL GOWN/TOGA
    Manufacturer
    MICROTEK MEDICAL, INC.
    Date Cleared
    2007-01-25

    (120 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROTEK MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE SURGICAL GOWN/TOGA IS INTENDED TO BE WORN Room BOTH THE SURG PROCEDURES TO PROTE RODM PERSONAL TRANSFER OF MICROORGANIST ARTICULATE MATER MATERIAL
    Device Description
    The Microtek gown/toga consists of a non-woven material and woven cuff material manufactured to protect the wearer and patient from contamination during various procedures throughout the clinical setting. This gown/toga is similar to other gowns/togas currently being marketed for the same intended use.
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    K Number
    K060200
    Device Name
    MICROTEK MEDICAL WARMING DRAPE
    Manufacturer
    MICROTEK MEDICAL, INC.
    Date Cleared
    2006-05-31

    (125 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROTEK MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Microtek Medical, Inc. Patient Warming Drape is intended to be used to provide patient warming during a variety of surgeries or procedures in the clinical setting.
    Device Description
    The Microtek Patient Warming Drape consists of a non-woven surgical drape, similar to other surgical drapes currently being marketed, with the exception of an added channel (with holes) that is adhered to the drape and allows the passage of warm air.
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    K Number
    K050322
    Device Name
    MICROTEK EQUIPMENT DRAPES
    Manufacturer
    MICROTEK MEDICAL, INC.
    Date Cleared
    2005-05-17

    (97 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROTEK MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MICROTEK MEDICAL EQUIPMENT DRAPES ARE TO BE USED TO COVER A VARIETY OF SURGICAL AND NON-SURGICAL EQUIPMENT IN VARIOUS SETTINGS THE CHOUSE HOUSE THE CUNICAL SETTING. THESE DRAPES ARE USED TO PROFECT THE OQUIPMENT FROM CONTAMINATION DURING VARIOUS PROCEOURES.
    Device Description
    The Microtek Equipment Drapes consist of poly film and non-woven material, separately and in combination, manufactured to protect a variety of surgical and non-surgical equipment from contamination during various procedures throughout the clinical setting. These equipment drapes are similar to other equipment drapes currently being marketed for the same intended use.
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    K Number
    K022903
    Device Name
    CHILLBUSTER
    Manufacturer
    MICROTEK MEDICAL, INC.
    Date Cleared
    2002-11-27

    (85 days)

    Product Code
    DWJ
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROTEK MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ChillBuster™ Portable Electric Blanket is to be used to reduce the effects of hypothermia encountered during the trauma of a surgical procedure or other medical crisis which could result in the onset of a hypothermic condition.
    Device Description
    The ChillBuster™ Portable Electric Blanket System is made up of six major components: Blanket, Control Module, Cabling, Battery, AC adapter, Carrying Bag.
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    K Number
    K020956
    Device Name
    VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA
    Manufacturer
    MICROTEK MEDICAL, INC.
    Date Cleared
    2002-05-16

    (52 days)

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

    MICROTEK MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VivoSonic™ will be used during invasive medical diagnostic ultrasound imaging to couple sound waves between patient and medical imaging electronics and to lubricate the insertion and passage of imaging devices, such as ultrasound transducers and endoscopes. VivoSonic™ is intended for use in conjunction with transcutaneous ultrasound image guided biopsy and aspiration, intraoperative ultrasound imaging, endocavity ultrasound imaging and opthalmic ultrasound imaging. VivoSonic™ is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound procedures which currently use and ultrasound coupling gel or fluid alone or in combination with a latex, non-latex, polyurethane or polyethylene transducer cover where sterility and/or in vivo biocompatibility are required.
    Device Description
    VivoSonic™ is an in vivo biocompatible sterile ultrasound couplant and lubricant that couples or conducts ultrasound between the body and the ultrasound transducer and electronics. The VivoSonic™ formulation is in vivo biocompatible with tissue and body fluids and is recognized as safe for oral administration (1)
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    K Number
    K011318
    Device Name
    VENODYNE DVT ADVANTAGE PLUS
    Manufacturer
    MICROTEK MEDICAL, INC.
    Date Cleared
    2001-10-25

    (177 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROTEK MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001802
    Device Name
    VENODYNE DVT ADVANTAGE MODEL 610
    Manufacturer
    MICROTEK MEDICAL, INC.
    Date Cleared
    2001-01-09

    (209 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROTEK MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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