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510(k) Data Aggregation

    K Number
    K042352
    Device Name
    BIODERM SCIENCES WOUND CREAM
    Manufacturer
    BIODERM SCIENCES, INC.
    Date Cleared
    2005-10-17

    (413 days)

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

    BIODERM SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BioDerm Sciences Wound Cream is intended to externally manage dermal lessions such as lacerations, post-operative (surgical) wounds, partial and full-thickness wounds, 15 and 200 as racerations, post operative (cargenous stasis, pressure). It may also be used in conjunction with a dressing that absorbs fluids (i.e. gauze, gel, alginate, foam, hydrocolloid).
    Device Description
    BioDerm Sciences Wound cream is an aqueous-based, acidic zinc/iron-saline cream for external wound management. It aids the body in the healing process by providing a moist, low pH wound environment and providing essential minerals. BioDerm Sciences Wound Cream is supplied in 100 g aluminum tubes. A metal seal at the tip of the tube must be broken in order to use the contents, thus rendering the packaging tamper-resistant. The dressing is applied by squeezing the cream from the tube onto the affected skin.
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    K Number
    K042084
    Device Name
    BIODERM SCIENCES WOUND HEALING SPRAY
    Manufacturer
    BIODERM SCIENCES, INC.
    Date Cleared
    2005-06-15

    (316 days)

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

    BIODERM SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BioDerm Sciences Wound Spray is intended to cleanse, rinsc and externally manage dermal lesions such as lacerations, post-operative (surgical) wounds, partial and full-thickness wounds, burns and ulcers (diabetic, venous stasis, pressure). It may also be used in conjunction with a dressing that absorbs fluids (i.e. gauze, gel, alginate, foam, hydrocolloid). BioDerm Sciences Wound Spray is intended to clean, rinse and externally manage skin wounds such as minor lacerations, minor cuts, minor burns and abrasions.
    Device Description
    BioDerm Wound Spray is an acidic zinc-saline wet dressing for external wound management. It aids the body in the healing process by providing a moist, acidic wound environment. The non-irritating components of BioDerm Wound Spray allow it to be used in the mouth, eyes and on mucous membrancs as well as on the skin. BioDerm Wound Spray is similar in chemical composition to the previously cleared BioDerm Scicnces Wound Solution with the spray also containing 0.002% of some trace elements. A difference between these products is that the predicate device BioDerm Scicnccs Wound Solution is supplied sterile in injection bottles, while the current device is supplied non-sterile in pump-spray bottles. The dressing is applied by spraying onto the affected arca. BioDerm Wound Spray is supplied in 100 ml spray bottles with a plunger activated pump applicator.
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    K Number
    K040683
    Device Name
    BIODERM SCIENCES WOUND DRESSING
    Manufacturer
    BIODERM SCIENCES, INC.
    Date Cleared
    2004-06-04

    (80 days)

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

    BIODERM SCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BioDerm Sciences Wound Solution is intended to cleanse, irrigate and externally manage dermal lesions such as lacerations, post-operative (surgical) wounds, grafts, partial and fullthickness wounds, burns and ulcers (diabetic, venous stasis, pressure). It is meant to be used in conjunction with a sterile dressing that absorbs fluids (i.e. gauze, gel, alginate, foam, hydrocolloid). BioDerm Wound Solution can also be used as a wound cleanser to remove foreign matter, bacteria and tissue debris.
    Device Description
    Bio Derm Wound Solution is an acidic zinc-saline wet dressing for external wound management. It provides an acidic, moist environment that aids the body in the healing process. The non-toxic nature of the solution allow it to be used in the mouth, eyes and on mucous membranes as well as on the skin. BioDerm Wound Solution is supplied sterile in 50 ml injection bottles with Teflon septums. The solution is applied by withdrawing the contents from the injection bottle with a syringe. The crimp caps have a pull-tab which must be removed to get the syringe through the septum. The pull-tab supplies whether the bottle has been opened or not. The contents must be used within five days after opening.
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