Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K023643
    Device Name
    MACROPORE SURGICAL BARRIER FILM
    Manufacturer
    MACROPORE BIOSURGERY, INC.
    Date Cleared
    2003-02-21

    (114 days)

    Product Code
    MTZ
    Regulation Number
    886.3320
    Why did this record match?
    Product Code :

    MTZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MacroPore Barrier Film is indicated for use as an orbital implant wrap to cover orbital implants used in enucleation surgery and to protect the surrounding orbital tissue from the surface of the implant.
    Device Description
    MacroPore Surgical Barrier Film is a resorbable implant in sheet form manufactured from polylactides (PLA). MacroPore Surgical Barrier Film can be cut with scissors to the desired shape and size. MacroPore Surgical Barrier Film is fully malleable when heated to approximately 55°C (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPore Surgical Barrier Film is provided in various shapes such as squares, rectangles, ovals, and circles. The MacroPore Surgical Barrier Film will be provided in sheets of 30mm x 30mm to 200mm x 200mm so that the surgeon may cut specific shapes and sizes. The thickness of the MacroPore Surgical Barrier Film will range from 0.05 mm to 1.0 mm. The MacroPore Surgical Barrier Film will be provided in solid sheets and in porous sheets that have pores that range in pore size from 0.5mm to 3.0mm with pores distributed randomly or uniformly throughout the film in an offset or aligned pattern. The pores are spaced at a distance of 1.5mm or greater. The MacroPore Surgical Barrier Film is fabricated from polylactide (PLA).
    Ask a Question
    K Number
    K973552
    Device Name
    OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP
    Manufacturer
    BIO-VASCULAR, INC.
    Date Cleared
    1997-12-16

    (88 days)

    Product Code
    MTZ
    Regulation Number
    886.3320
    Why did this record match?
    Product Code :

    MTZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ocu-Guard™ and Supple Ocu-Guard™ are indicated for use as an orbital implant wrap to cover any type or shape of orbital implant used in enucleation surgery. The product is easy to handle and trim and conforms to the shape of the Implant. Ocu-Guard and Supple Ocu-Guard allow for tissue ingrowth through the vascularization process and protect the surrounding orbital tissue from the surface of the orbital implant, decreasing the risk of implant exposure. Ocu-Guard and Supple Ocu-Guard also allow for muscle reattachment to facilitate motility of the implant.
    Device Description
    Ocu-Guard™ Orbital Implant Wrap and Supple Ocu-Guard™ Orbital Implant Wrap. Both products are composed of bovine pericardium, cross-linked (tanned) with glutaraldehyde. Ocu-Guard and Supple Ocu-Guard will be available in configurations ranging from 4cmx4cm to 10cmx16cm. Ocu-Guard and Supple Ocu-Guard will also be available as a "pre-formed" wrap. The "pre-formed" wrap will be available in configurations which will fit implant spheres ranging from 14 mm to 22 mm in size.
    Ask a Question

    Page 1 of 1