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510(k) Data Aggregation

    K Number
    K090773
    Device Name
    CFI ULTRASOUND PROBE DRAPE
    Date Cleared
    2009-09-18

    (179 days)

    Product Code
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONTOUR FABRICATORS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    These ultrasound probe drape devices are intended for use by or as directed by a licensed medical practitioner during a medical ultrasound imaging procedure involving limited-duration unbroken-skin patient contact, to provide for maintenance of a sterile field (sterile covers only), to help protect the patient and healthcare worker from transfer of contaminants and biological risk agents (sterile and non-sterile covers), and to protect the ultrasound probe from contamination that could adversely affect its functionality or create downtime and require cleaning procedures (sterile and non-sterile covers). These single patient/procedure, disposable devices are furnished sterile, in most cases as an element of a kit-product that also includes a foil packet of ultrasound coupling gel, which always is pre-sterilized.
    Device Description
    Contour Fabricators, Inc. Ultrasound Probe Drapes provide an efficient flexible covering to fit various specific ultrasound probes. These ultrasound probe drapes are constructed primarily of polyurethane film, a customary ultrasound probe drape material. Some drape designs additionally utilize an inner layer of polyethylene film to provide an extended cable cover. This extended cable cover has no patient contact and, at most, incidental user contact. Most product versions include a pre-sterilized foil packet of ultrasound coupling gel and two sterile synthetic elastomer (non-latex) bands that are customarily used to control extra "bulk" of drape material in the vicinity of the application procedure. Each Ultrasound Probe Drape is roll- or telescope-folded during its manufacturing to facilitate user application to the ultrasound probe. Each folded Ultrasound Probe Drape then is wrapped with a suitable piece of "CSR-wrap" (medical paper customarily used for this purpose). The wrapped, folded Ultrasound Probe Drape is then placed, along with the pre-sterilized foil packet of ultrasound coupling gel and the synthetic elastomer bands if provided, into a medical device pouch for terminal sterilization and distribution.
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    K Number
    K970900
    Device Name
    INSTRUMENT HOLDER
    Date Cleared
    1997-05-22

    (72 days)

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

    CONTOUR FABRICATORS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The disposable, sterile instrument holder is intended to be an easily positioned sterile support for surgical instruments. Pressure sensitive adhesive strips are included to allow easy application of the holder to a dry operating room surface. Examples of possible instruments held by this device are lightweight microsurgical instruments, bipolar forceps, or suction tube tips.
    Device Description
    The sterile, disposable instrument holder is made of 8 mil vinyl. The overall dimensions of the device are 7.25" x 8.5". The vinyl is heat sealed to create 6 pockets to allow for easy instrument storage and retrieval. Pocket sizes are as follows: (1) pocket at 4"x3.75", (1) pocket at 4"x6", (2) pockets at 2"x3.75", (2) pockets at 2"x6"
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    K Number
    K971040
    Device Name
    CABLE HOLDER, SUCTION TUBE HOLDER
    Date Cleared
    1997-04-16

    (26 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONTOUR FABRICATORS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The sterile, disposable cable or tube holder is intended to limit the amount of excess cable or tubing that extends into the surgical field. The holders are offered in 1/2" and 3/4" sizes to allow for a variety of diameters. Pressure sensitive adhesive is attached to the back of both sizes to allow for easy attachment to a clean, dry surface.
    Device Description
    The cable or suction tube holder is a sturdy nylon construction available in 1/2" or 3/4" diameter. Pressure sensitive adhesive backing allows for the holders to be positioned on a clean, dry surface. Flexible lock and release loops allow the cable or tube to be retained and held in place.
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    K Number
    K970185
    Device Name
    STERILE DISPOSABLE EQUIPMENT MAGNET COVER
    Date Cleared
    1997-04-10

    (83 days)

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

    CONTOUR FABRICATORS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Magnetic Resonance Imaging (MRI) technology requires the use of large magnets for image generation. This technology is now being tested for use in surgical procedures. The sterile, disposable magnet cover is intended to protect the walls of a magnet from gross contamination and also to isolate the sterile field from microbial contamination. This particular cover is specifically intended for use with the General Electric Medical Systems Signa SP MRI system.
    Device Description
    The sterile, disposable magnet cover utilizes a Dexter Nonwoven: a soft, strong absorbent pinhole resistant base fabric, which has been coated with .5 mil of linear low density polyethylene extrusion. The material is blue in color, cut to an overall length and width of 114" x 54", and is 5 mils thick. Through the use of pressure sensitive adhesive tape, the cover can be attached to a clean, dry surface to establish a barrier.
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    K Number
    K964141
    Device Name
    GE STERILE DISPOSABLE EQUIPMENT COIL COVER
    Date Cleared
    1997-01-30

    (107 days)

    Product Code
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONTOUR FABRICATORS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The GE Sterile Disposable Equipment Cover is intended to protect equipment from fluids. Specifically, a coil used in the GE Magnetic Resonance Imaging (MRI) System.
    Device Description
    An MRI system requires the use of a remote transmitting coil to generate the localized images. The coil is placed on the area of the patient where the operating incision is made. The coil itself resembles a window frame. These coils are very suspectible to damage caused by various fluids that may be release during an invasive procedure. To protect these coils, a Sterile Disposable Equipment Cover is used to seal the coil inside a wrapper preventing it from fluid contamination. The Sterile Disposable Equipment Cover is made from PVC Film and the strap is polynap of 100% nylon fabric with polyester foam core and nylon tricot backing.
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    K Number
    K963453
    Device Name
    CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046)
    Date Cleared
    1996-11-15

    (73 days)

    Product Code
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONTOUR FABRICATORS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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