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510(k) Data Aggregation

    K Number
    K240817
    Device Name
    VersaWrap
    Manufacturer
    Alafair Biosciences Inc.
    Date Cleared
    2024-06-14

    (81 days)

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

    Alafair Biosciences Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VersaWrap is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The device may also be used in the management and protection of surrounding tissues such as skeletal muscle and ligaments. In these procedures, VersaWrap may encounter a variety of implanted structures such as anchors, grafts, staples, and sutures.
    Device Description
    VersaWrap® is an absorbable implant (device), designed to serve as an interface between the target tissues to provide a non-constricting, protective encasement. VersaWrap consists of a clear hydrogel (Sheet) and a wetting Solution. The clear Sheet is a thin membrane of alginate and hyaluronic acid. VersaWrap Sheet is easy to handle, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap may encounter a variety of implanted structures such as anchors, grafts, staples. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet a gelatinous, tissue adherent layer (gel). The Solution, comprised of aqueous citrate, is provided sterile, non-pyrogenic, for single use, in a double peel pouch.
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    K Number
    K232029
    Device Name
    VersaWrap Nerve Protector
    Manufacturer
    Alafair Biosciences Inc
    Date Cleared
    2023-11-02

    (118 days)

    Product Code
    JXI
    Regulation Number
    882.5275
    Why did this record match?
    Applicant Name (Manufacturer) :

    Alafair Biosciences Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VersaWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
    Device Description
    VersaWrap Nerve Protector (VersaWrap) is designed to function as an interface between an injured nerve and surrounding tissues and is indicated for use in peripheral nerve injuries where there is no significant loss of nerve tissue. VersaWrap Nerve Protector is a thin, flexible implant, designed to be a non-constricting gelatinous interface encasing peripheral nerves and the neural environment; that starts to absorb after implant. VersaWrap Nerve Protector is designed to be flexible and conformable for placement around a peripheral nerve.
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    K Number
    K213163
    Device Name
    VersaWrap
    Manufacturer
    Alafair Biosciences Inc
    Date Cleared
    2021-10-29

    (31 days)

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

    Alafair Biosciences Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VersaWrap is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The device may also be used in the management and protection of surrounding tissues such as skeletal muscle and ligament.
    Device Description
    VersaWrap® is an absorbable implant (device), designed to serve as an interface between the target tissues and surrounding tissues to provide a non-constricting, protective encasement. VersaWrap consists of a clear Sheet and a wetting Solution. The clear Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan (GAG). VersaWrap Sheet is easy to handle, conformable, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet rendering the Sheet a gelatinous, tissue adherent layer. The Solution, comprised of aqueous citrate, is provided sterile, non-pyrogenic, for single use, in a dropper, packaged in a double peel pouch.
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    K Number
    K203600
    Device Name
    VersaWrap
    Manufacturer
    Alafair Biosciences Inc
    Date Cleared
    2021-03-09

    (90 days)

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

    Alafair Biosciences Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VersaWrap is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The device may also be used in the management and protection of surrounding tissues such as skeletal muscle and ligament.
    Device Description
    VersaWrap® is an absorbable implant (device), designed to serve as an interface between the target tissues and surrounding tissues to provide a non-constricting, protective encasement. Versa Wrap consists of a clear Sheet and a wetting Solution. The clear Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan (GAG). VersaWrap Sheet is easy to handle, conformable, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet after the Sheet is positioned. The Solution, comprised of aqueous citrate, is provided sterile, non-pyrogenic, for single use, in a dropper, packaged in a double peel pouch.
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    K Number
    K201631
    Device Name
    VersaWrap Nerve Protector
    Manufacturer
    Alafair Biosciences Inc
    Date Cleared
    2020-09-14

    (90 days)

    Product Code
    JXI
    Regulation Number
    882.5275
    Why did this record match?
    Applicant Name (Manufacturer) :

    Alafair Biosciences Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VersaWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
    Device Description
    VersaWrap Nerve Protector (VersaWrap) is designed to function as an interface between an injured nerve and surrounding tissues and is indicated for use in peripheral nerve injuries where there is no significant loss of nerve tissue. VersaWrap Nerve Protector is a thin, flexible implant, designed to be a non-constricting gelatinous interface encasing peripheral nerves and the neural environment; that starts to absorb after implant. VersaWrap Nerve Protector is designed to be flexible and conformable for placement around a peripheral nerve
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    K Number
    K200311
    Device Name
    VersaWrap Tendon Protector
    Manufacturer
    Alafair Biosciences Inc
    Date Cleared
    2020-03-06

    (29 days)

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

    Alafair Biosciences Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VersaWrap is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
    Device Description
    VersaWrap is an absorbable implant (device), designed to serve as an interface between the tendon and tendon sheath or the surrounding tissues, which provides a non-constricting, protective encasement for injured tendons. VersaWrap consists of a Sheet and a Wetting Solution. The Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan. VersaWrap Sheet is easy to handle, conformable, and is designed for easy placement under, around, or over the injured tendon. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet after the Sheet is positioned onto damaged tissue. The Solution is comprised of aqueous citrate and is provided in a dropper packaged in a double peel pouch. The Solution is sterile, non-pyrogenic, and is intended for single use only.
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    K Number
    K160364
    Device Name
    VersaWrap Tendon Protector
    Manufacturer
    Alafair Biosciences Inc
    Date Cleared
    2016-06-10

    (122 days)

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

    Alafair Biosciences Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VersaWrap Tendon Protector is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
    Device Description
    VersaWrap is an absorbable implant (device), designed to serve as an interface between the tendon and tendon sheath or the surrounding tissues, which provides a non-constricting, protective encasement for injured tendons. VersaWrap consists of a Sheet and a wetting Solution. The Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan. VersaWrap Sheet is easy to handle, conformable, and is designed for easy placement under, around. or over the injured tendon. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet after the Sheet is positioned onto damaged tissue. The Solution is comprised of aqueous citrate and is provided in a dropper packaged in a double peel pouch. The Solution is sterile, non-pyrogenic, and is intended for single use only.
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