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510(k) Data Aggregation

    K Number
    K240753
    Device Name
    Miro3D Fibers Wound Matrix
    Date Cleared
    2024-04-19

    (30 days)

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

    Reprise Biomedical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Miro3D Fibers Wound Matrix is intended for the management of wounds including: · Partial and full thickness wounds - · Pressure ulcers - · Venous ulcers - · Chronic vascular ulcers - · Diabetic ulcers - · Tunneled, undermined wounds - · Trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears) - · Draining wounds - · Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence)
    Device Description
    The Miro3D Fibers Wound Matrix is a sterile, single use, non-crosslinked acellular wound dressing that is derived from porcine liver tissue. The liver is perfusion decellularized resulting in a collagen matrix that is dried and cut into fibers. The device is packaged dry and terminally sterilized in its packaging by e-beam irradiation. The Miro3D Fibers Wound Matrix may be used dry or rehydrated and is provided in four sizes by weight.
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    K Number
    K240277
    Device Name
    MiroDry Wound Matrix
    Date Cleared
    2024-03-01

    (30 days)

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

    Reprise Biomedical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MiroDry Wound Matrix is intended for the management of wounds including: · Partial and full thickness wounds - · Pressure ulcers - · Venous ulcers - · Chronic vascular ulcers - · Diabetic ulcers - · Tunneled, undermined wounds - · Trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears) - · Draining wounds - · Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence)
    Device Description
    The MiroDry Wound Matrix is a sterile, single use, non-crosslinked acellular wound dressing that is derived from porcine liver tissue. The liver is perfusion decellularized resulting in a collagen matrix that is dried and cut to defined sizes. The device is packaged dry, terminally sterilized in its packaging by e-beam irradiation and is rehydrated with sterile saline or Lactated Ringer's solution prior to use. The MiroDry Wound Matrix is provided in six sizes that may be cut to fit a wound size prior to application.
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    K Number
    K231614
    Device Name
    MiroTract Wound Matrix
    Date Cleared
    2023-12-13

    (194 days)

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

    Reprise Biomedical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MiroTract Wound Matrix is intended for the management of wounds including: · Partial and full thickness wounds - Pressure ulcers - Venous ulcers - · Chronic vascular ulcers - · Diabetic ulcers - · Tunneled, undermined wounds - · Trauma wounds (abrasions, lacerations, partial-thickness burns, and skin tears) - · Draining wounds · Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence)
    Device Description
    The Reprise Biomedical MiroTract device consists of the MiroTract Wound Matrix and disposable delivery system. The MiroTract Wound Matrix is a sterile, single use, noncrosslinked acellular wound dressing that is derived from porcine liver tissue. The porcine liver is perfusion decellularized resulting in a collagen matrix that is dried, cut to size, and radially compressed onto the guidewire of the MiroTract delivery system. The delivery system includes a guidewire and tamp tube to manually push the MiroTract Wound Matrix off the guidewire into a wound. The MiroTract Wound Matrix porous scaffold provides a protective environment for wound healing. The MiroTract Wound Matrix is provided in two diameters (3 mm and 5 mm) and two lengths (5 cm and 9 cm). The MiroTract device is packaged dry in a plastic tray placed inside a foil pouch. The device is terminally sterilized in its packaging by e-beam irradiation. An optional Introducer Set accessory consisting of a tearaway sheath and dilator is provided in a separately packaged sterile pouch that is placed in a shelf box along with a MiroTract packaged device.
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    K Number
    K221520
    Device Name
    Miro3D Wound Matrix
    Date Cleared
    2022-08-18

    (85 days)

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

    Reprise Biomedical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Miro3D Wound Matrix is intended for the management of wounds including: - Partial and full thickness wounds - Pressure ulcers - Venous ulcers - Chronic vascular ulcers - Diabetic ulcers - Tunneled, undermined wounds - Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) - Draining wounds - Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence)
    Device Description
    The Reprise Miro3D Wound Matrix is a sterile, single use, non-crosslinked acellular wound dressing that is derived from porcine liver tissue. The liver is perfusion decellularized resulting in a collagen matrix that is dried and cut to defined sizes. The Miro3D porous scaffold provides a protective environment for wound healing. The device is packaged dry, terminally sterilized in its packaging by e-beam irradiation and is rehydrated with sterile saline or lactated Ringer's solution prior to use. The Miro3D Wound Matrix is provided in four sizes that may be cut to fit a wound size prior to application.
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