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510(k) Data Aggregation

    K Number
    K172010
    Device Name
    gel-e Bandage
    Manufacturer
    gel-e, Inc. (formerly Remedium Technologies, Inc.)
    Date Cleared
    2017-12-07

    (157 days)

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

    (formerly Remedium Technologies, Inc.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The gel-e Bandage is indicated for the management of moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision the gel-e Dressing may be used for management of: - Pressure sores - Diabetic ulcers - Leg ulcers - Donor sites and graft sites - Surgical wounds - Skin abrasions and lacerations - 1st and 2nd degree burns - Trauma wounds Over-The-Counter Use (21 CFR 801 Subpart C): - The gel-e Bandage may be used for the management of: - Minor cuts - Minor scalds and 1st degree burns - Abrasions - Lacerations
    Device Description
    Gel-e Bandage is a sterile topical bandage comprising a lyophilized chitosanbased patch attached to a standard bandage backing with two adhesive strips on either side of the patch for secure attachment to skin. The gel-e Bandage is absorbent and conformable. As wound exudate is absorbed into the chitosanbased patch, the patch forms a gel, which maintains a moist environment for optimal wound healing, and allows intact removal. The gel-e Bandage is intended for use as a primary dressing for a variety of chronic and acute wounds. It secured onto skin by manually pressing the adhesive strips on either side of the patch. Dressings are individually packed into aluminum foil pouches and terminally sterilized to achieve an SAL of 10-6.
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    K Number
    K143466
    Device Name
    Hemogrip Patch
    Manufacturer
    REMEDIUM TECHNOLOGIES, INC.
    Date Cleared
    2015-06-08

    (186 days)

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

    REMEDIUM TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hemogrip™ Patch is indicated for use, under the direction of a healthcare professional, in the management of bleeding wounds such as vascular access sites and percutaneous catheters or tubes.
    Device Description
    The Hemogrip™ Patch Hemostasis Pad is a non-invasive topical bandage intended to promote hemostasis when in contact with a bleeding wound. Hemogrip™ Patch is composed of a soft, sterile, palmitoyl-N-acetylglucomasine substrate/backing coated with a freeze-dried layer of poly N-acetylglucosamine (chitosan). The environment of use for the Hemogrip™ Patch is at a healthcare facility/hospital under the direction of a healthcare professional. The Hemogrip™ Patch Hemostasis Pad promotes the control of bleeding wounds in patients. This is achieved by applying proximal pressure to the puncture site and placing a Hemogrip™ Patch over the puncture site using a sterile folded gauze. Firm compression is applied over the puncture site until hemostasis is achieved. Proximal pressure can be released after 2 to 3 minutes. Once hemostasis is achieved, pressure is released and a dry gauze is placed over the Hemogrip" Patch. The site is then covered with an appropriate dressing. Within 24 hours, Hemogrip™ Patch should be soaked with water and gently removed. The Hemogrip™ Patch is sterilized via y-irradiation and is for single use only.
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