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510(k) Data Aggregation

    K Number
    K091354
    Device Name
    ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING
    Manufacturer
    ACRYMED, INC.
    Date Cleared
    2009-10-21

    (166 days)

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

    ACRYMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AcryDerm Silver Antimicrobial Foam Wound Dressing is indicated for the management of 1st and 2nd degree burns, wounds such as venous and arterial ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.
    Device Description
    AcryDerm Silver Antimicrobial Foam Wound Dressings are sterile, single use hydrophilic polyurethane foam dressings containing antimicrobial silver for use in the management of wounds.
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    K Number
    K083103
    Device Name
    ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B
    Manufacturer
    ACRYMED, INC.
    Date Cleared
    2009-02-26

    (129 days)

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

    ACRYMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Under the supervision of a healthcare professional, AcryDerm Silver Antimicrobial Wound Gel Model #B is indicated for the management of 1ª and 2ª degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites. OTC: AcryDerm Wound Gel Model #B is indicated for the management of minor abrasions, cuts, lacerations and scalds.
    Device Description
    AcryDerm Antimicrobial Silver Gel Model #B is a repeat use, amorphous hydrogel containing antimicrobial silver for use in the management of wounds.
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    K Number
    K082459
    Device Name
    ACRYDERM ABSORBENT OXYGEN DRESSING
    Manufacturer
    ACRYMED, INC.
    Date Cleared
    2008-09-19

    (24 days)

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

    ACRYMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The new oxygen enriched topical hydrophilic closed cell foam wound dressings are indicated for use in the management of acute and chronic wounds. The products are intended as a primary topical wound contact dressings for use in the management of wound exudates for wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, first and second degree burns, lacerations, puncture wounds, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites. Over the Counter Use: AcryDerm Absorbent Oxygen Dressings are intended to be used on minor wounds including lacerations scrapes, skin tears, abrasions, blister wounds, and minor burns.
    Device Description
    AcryDerm Absorbent Oxygen Dressing is a single use, sterile, hydrophilic absorbent closed cell foam enriched with gaseous and dissolved oxygen intended for use in the management of wounds. The oxygen enriched product is intended to be used as a topical moisture management wound dressing.
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    K Number
    K070333
    Device Name
    ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL
    Manufacturer
    ACRYMED, INC.
    Date Cleared
    2007-07-10

    (155 days)

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

    ACRYMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AcryDerm Silver Antimicrobial OTC Wound Gel is intended for use on intact and broken skin and dermal injuries such as minor laceration, cuts, burns, scrapes and minor surgical procedures wounds.
    Device Description
    AcryDerm Silver Antimicrobial OTC Wound Gel is a moist amorphous gel wound filler that contains antimicrobial silver. It is supplied in collapsible blind ended heat sealed co-laminate tubes fitted with screw caps.
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    K Number
    K061232
    Device Name
    ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006
    Manufacturer
    ACRYMED, INC.
    Date Cleared
    2006-10-06

    (157 days)

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

    ACRYMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To secure devices such as indwelling catheters, drains, monitoring leads and airway management apparatus to patients skin. For use as a cover dressing or in direct contact of wounds such as pressure ulcers, stasis ulcers, sites, davice incention its cond degree burns, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donors sites.
    Device Description
    The new product is sterile single use silver antimicrobial adherent transparent film. Sterility assurance will conform to AAMI/ANSI/ISO 11137-1994.
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    K Number
    K011994
    Device Name
    ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101
    Manufacturer
    ACRYMED, INC.
    Date Cleared
    2001-11-08

    (135 days)

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

    ACRYMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AcryDerm Silver Antimicrobial Wound Gel is an amorphous wound moisture management gel that is an effective antimicrobial barrier. The antimicrobial barrier function of the dressing may help reduce the incidence of infection in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions and lacerations, donor sites and surgical wounds. AcryDerm Silver may be used over debrided and grafted partial thickness wounds.
    Device Description
    AcryDerm Silver Antimicrobial Wound Gel is a line extension of the previously cleared product, AcryDerm Gel Wound Dressing. The new product is a moist amorphous gel wound filler that contains antimicrobial silver that inhibits the growth of microbial contaminants in contact with the dressing. The high moisture content gel contains a base matrix composed of hydrophilic polyacrylate absorbent microspheres that contain a silver complex and stabilizers to prevent discoloration and staining from the dressing. AcryDerm Silver Antimicrobial Wound Gel will be supplied in collapsible blind ended heat sealed co-laminate foil tubes fitted with screw caps. The reusable product primaries will be packed in individual dispenser boxes with a product insert. Biocompatibility has been assessed according to Part-1 of the ISO standard (Biological Evaluation of Medical Devices).
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    K Number
    K012116
    Device Name
    ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING
    Manufacturer
    ACRYMED, INC.
    Date Cleared
    2001-09-12

    (68 days)

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

    ACRYMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AcryDerm Silver Antimicrobial Perforated Dressing is an effective barrier to bacterial penetration. The barrier function of the dressing may help reduce infection in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions and lacerations, donor sites and surgical wounds. AcryDerm Silver may be used over debrided and grafted partial thickness wounds.
    Device Description
    AcryDerm Silver Antimicrobial Perforated Dressing is a line extension of the previously cleared product, AcryDerm Silver Antimicrobial Strands. The new product is made from the same matrix material, has the same composition and is made using substantially an equivalent manufacturing process as the predicate. The new product is an absorbent, perforated wound dressing that contains antimicrobial silver that minimizes the growth of microbial contaminants in contact with the dressing. AcryDerm Silver Antimicrobial Perforated Dressing will be supplied sterile packaged in single use heat sealed medical grade poly-laminate pouches. The single use primaries will be packed into dispenser boxes for distribution. Biocompatibility has been assessed and it meets the requirements of ISO 10993-1 (Biological Evaluation of Medical Devices).
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    K Number
    K002909
    Device Name
    ACRYDERM SILVER ANTIMICROBIAL STRANDS MODEL A-020103
    Manufacturer
    ACRYMED, INC.
    Date Cleared
    2000-10-13

    (25 days)

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

    ACRYMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002599
    Device Name
    MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045
    Manufacturer
    ACRYMED, INC.
    Date Cleared
    2000-09-21

    (31 days)

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

    ACRYMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991818
    Device Name
    ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045
    Manufacturer
    ACRYMED, INC.
    Date Cleared
    2000-04-17

    (326 days)

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

    ACRYMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wound cover dressing for the following wounds: Acute Wounds such as: Surgical wounds, Lacerations, Donor site wounds, First and second degree burns, Skin tears, Abrasions. Chronic Wounds such as: Pressure sores, Diabetic ulcers, Venous stasis ulcers, Arterial stasis ulcers.
    Device Description
    AcryDerm Silver Antimicrobial Barrier Wound Dressing is a moist sheet wound dressing that contains silver halide that may help to reduce growth of microbial contaminants of the dressing. The base matrix is composed of a hydrophilic polyacrylate absorbent sheet containing silver halide and stabilizers. AcryDerm Silver Antimicrobial Barrier Wound Dressing will be supplied as sterile sheets of 2x2"; 4x4"; 4x8"; of 8x8" sizes, packaged in single use heat sealed medical grade foil pouches.
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