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510(k) Data Aggregation

    K Number
    K090637
    Device Name
    CARDIO-WRAP
    Manufacturer
    MAST BIOSURGERY USA INC.
    Date Cleared
    2010-01-07

    (303 days)

    Product Code
    DXZ
    Regulation Number
    870.3470
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAST BIOSURGERY USA INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cardio-Wrap Bioresorbable Sheet is intended for reconstruction and repair of defects of the pericardium.
    Device Description
    MAST Biosurgery Cardio-Wrap Bioresorbable Sheet is a resorbable implant in sheet form manufactured from polylactic acid (PLA). MAST Biosurgery Cardio-Wrap Bioresorbable Sheet can be cut with scissors to the desired shape and size. The MAST Biosurgery Cardio-Wrap can be used either alone or in conjunction with soft tissue fixation devices such as resorbable sutures, which can also serve to fixate the MAST Biosurgery Cardio-Wrap and prevent dislocation. MAST Biosurgery Cardio-Wrap Bioresorbable Sheet is provided in various shapes such as rectangles, ovals, and circles and will be provided in other shapes and sizes as needed for particular surgical procedures. MAST Biosurgery Cardio-Wrap Bioresorbable Sheet is provided in sheets of 10mm x 10mm to 500mm x 500mm and will be provided in other shapes and sizes as needed for particular surgical procedures. The thickness of the MAST Biosurgery Cardio-Wrap Bioresorbable Sheet ranges from 0.02 mm to 1.0 mm according to the region to be treated. The MAST Biosurgery Cardio-Wrap is provided in solid sheets. The borders of the sheets may be aligned with holes to attach suture material.
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    K Number
    K063648
    Device Name
    SURGI-WRAP MAST TENDON SHEET
    Manufacturer
    MAST BIOSURGERY USA INC.
    Date Cleared
    2007-03-07

    (90 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAST BIOSURGERY USA INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surgi-Wrap MAST Tendon Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The resorbable Protective Film minimizes tissue attachment to the device in case of direct contact with the tissues. The Surgi-Wrap MAST Tendon Sheet is also indicated for reinforcement of soft tissues repaired by suture or suture anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Surgi-Wrap MAST Tendon Sheet is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair. The Surgi-Wrap MAST Tendon Sheet reinforces soft tissue and provides a remodelable scaffold that is replaced by the patients own soft tissue. The device is indicated for open and laparoscopic / endoscopic procedures. Laparoscopic / endoscopic procedures are limited to sizes from 0.02mm - 0.2mm in thickness.
    Device Description
    The MAST Biosurgery Surgi-Wrap MAST Tendon Sheet is a resorbable implant in sheet form manufactured from poly (L-lactide-co-D,L-lactide) 70:30 (PLA). The Surgi-Wrap MAST Tendon Sheet can be cut with scissors to the desired shape and size. The Surgi-Wrap MAST Tendon Sheet Sheet is fully malleable when heated to approximately 55℃ (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The Surgi-Wrap MAST Tendon Sheet can be used either alone or in conjunction with soft tissue fixation devices such as resorbable sutures, which can also serve to fixate the Surgi-Wrap MAST Tendon Sheet and prevent dislocation. The Surgi-Wrap MAST Tendon Sheet may be used in conjunction with various MAST Biosurgery Class I manual instruments (forceps, scissors, clamps, etc.). The MAST Biosurgery Surgi-Wrap MAST Tendon Sheet is provided in various shapes such as rectangles, ovals, and circles and will be provided in other shapes and sizes as needed for particular surgical procedures. The MAST Biosurgery Surgi-Wrap MAST Tendon Sheet is provided in sheets of 25mm x 25mm to 500mm x 500mm and will be provided in other shapes and sizes as needed for particular surgical procedures. The thickness of the MAST Biosurgery Surgi-Wrap MAST Tendon Sheet ranges from 0.02 mm to 1.0 mm according to the region to be treated. The MAST Biosurgery Surgi-Wrap MAST Tendon Sheet is provided in solid sheets. The borders of the sheets may be aligned with holes to attach suture material.
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    K Number
    K061473
    Device Name
    SURGI-WRAP MAST BIORESORBABLE SHEET
    Manufacturer
    MAST BIOSURGERY USA INC.
    Date Cleared
    2006-09-21

    (114 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAST BIOSURGERY USA INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surgi-Wrap MAST Bioresorbable Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The resorbable Protective Film minimizes tissue attachment to the device in case of direct contact with the tissues. The device is indicated for open and laparoscopic / endoscopic procedures. Laparoscopic / endoscopic procedures are limited to sizes from 0.02mm - 0.2mm in thickness.
    Device Description
    The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet is a resorbable implant in sheet form manufactured from polylactic acid (PLA). The Surgi-Wrap MAST Bioresorbable Sheet can be cut with scissors to the desired shape and size. The Surgi-Wrap MAST Bioresorbable Sheet is fully malleable when heated to approximately 55℃ (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The Surgi-Wrap MAST Bioresorbable Sheet can be used either alone or in conjunction with soft tissue fixation devices such as resorbable sutures, which can also serve to fixate the Surgi-Wrap MAST Bioresorbable Sheet and prevent dislocation. The Surgi-Wrap MAST Bioresorbable Sheet may be used in conjunction with various MAST Biosurgery Class I manual instruments (forceps, scissors, clamps, etc.). The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet is provided in various shapes such as rectangles, ovals, and circles and will be provided in other shapes and sizes as needed for particular surgical procedures. The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet is provided in sheets of 25mm x 25mm to 500mm x 500mm and will be provided in other shapes and sizes as needed for particular surgical procedures. The thickness of the MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet ranges from 0.02 mm to 1.0 mm according to the region to be treated. The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet is provided in solid sheets. The borders of the sheets may be aligned with holes to attach suture material.
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    K Number
    K050332
    Device Name
    SURGI-WRAP MAST BIORESORBABLE SHEET
    Manufacturer
    MAST BIOSURGERY USA INC.
    Date Cleared
    2005-05-27

    (106 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAST BIOSURGERY USA INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surgi-Wrap MAST Bioresorbable Sheet is to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse, repair, reconstruction of the pelvic floor and sacral colposuspension. The resorbable Protective Film minimizes tissue attachment to the device in case of direct contact with the viscera. The device is indicated for open and laparoscopic procedures. Laparoscopic procedures are limited to sizes from 0.02mm - 0.2mm in thickness.
    Device Description
    MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet is a resorbable implant in sheet form manufactured from polylactic acid (PLA). The Surgi-Wrap MAST Bioresorbable Sheet can be cut with scissors to the desired shape and size. The Surgi-Wrap MAST Bioresorbable Sheet Sheet is fully malleable when heated to approximately 55℃ (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The Surgi-Wrap MAST Bioresorbable Sheet can be used either alone or in conjunction with soft tissue fixation devices such as resorbable sutures, which can also serve to fixate the Surgi-Wrap MAST Bioresorbable Sheet and prevent dislocation. The Surgi-Wrap MAST Bioresorbable Sheet may be used in conjunction with various MAST Biosurgery Class I manual instruments (forceps, scissors, clamps, etc.). The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet is provided in various shapes such as rectangles, ovals, and circles and will be provided in other shapes and sizes as needed for particular surgical procedures. The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet is provided in sheets of 25mm x 25mm to 500mm x 500mm and will be provided in other shapes and sizes as needed for particular surgical procedures. The thickness of the MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet ranges from 0.02 mm to 1.0 mm according to the region to be treated. The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet is provided in solid sheets. The borders of the sheets may be aligned with holes to attach suture material.
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