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510(k) Data Aggregation
(268 days)
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(259 days)
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(254 days)
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(255 days)
Redermax Antibacterial Wound Matrix is intended for the management of wounds. Redermax Antibacterial Wound Matrix is indicated for the management of:
- Partial and full thickness wounds
- Pressure ulcers
- Venous ulcers
- Diabetic ulcers
- Chronic vascular ulcers
- Tunneled/undermined wounds
- Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence)
- Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
- Draining wounds.
Redermax Antibacterial Wound Matrix is a sterile, single-use device intended for use in the management of wounds. Redermax is a soft, white, conformable, non-friable, absorbable, three-dimensional matrix that provides an environment for the body's healing process to occur. Redermax is supplied dry in sheet form. The device consists of composite fibers made from biocompatible and biodegradable materials. With the defined rate of absorption, the matrix provides a structural structure for wound healing before complete degradation through hydrolysis. Redermax is a porous matrix composed of poly(lactic-glycolic acid) (PLGA), polydioxanone (PDO), Poloxamer 188, and poly (hexamethylene biguanide) hydrochloride (PHMB), and based on in vitro testing, the PHMB effectively reduces the growth of bacteria within the Redermax Wound Matrix for a period of up to 7 days. The device does not contain any human or animal materials or tissue.
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(162 days)
New Day Skin Spray is a skin emulsion indicated for the management of dryness of skin, and atopic dermatitis. New Day Skin Spray maintains a moist skin and wound environment beneficial to the healing process.
The New Day Skin Spray is a skin emulsion designed to manage atopic dermatitis. A thin layer is to be applied to the affected area for up to 28 days or until symptoms subside. The applied thin layer of New Day Skin Spray forms a breathable layer by maintaining a moist wound and skin environment, which is beneficial to the healing process.
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(293 days)
The SBC1 Cream is a skin emulsion indicated for management of pruritus and dryness of skin in atopic dermatitis and allergic contact dermatitis. Not to be used on breached or compromised skin or open sores.
SBC1 Cream is a fragrance free, preserved, non-sterile, topical skin emulsion indicated for management of pruritus and dryness of skin in atopic dermatitis and allergic contact dermatitis. SBC1 Cream supports a moist environment. SBC1 Cream is provided prescription only in various sizes for single patient use.
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(132 days)
Rx use: revyve® Antimicrobial Skin and Wound Cleanser for prescription use is intended for use under the supervision of healthcare professionals for mechanical cleansing, moistening, debriding, and removal of foreign material including microorganisms and debris from wounds, including acute and chronic dermal lesions, such as Stage I - IV pressure ulcers, venous ulcers, leg ulcers, diabetic foot ulcers, post-surgical wounds, first and superficial second degree burns, grafted and donor sites. It is also intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions.
OTC use: revyve® Antimicrobial Skin and Wound Cleanser for OTC use is intended for mechanical cleansing wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations, and minor burns.
revyve® Antimicrobial Skin and Wound Cleanser is a clear, colorless liquid containing poloxamer 407, EDTA, sodium citrate/citric acid, polyhexanide (PHMB) and glycerol. PHMB at a concentration of 0.1% w/w is added as preservative to prevent microbial growth, within the product during shelf-storage. This skin and wound cleanser will be packaged in 4 fluid oz (118.3 mL) polyethylene squeeze bottle. revyve® Antimicrobial Skin and Wound and Cleanser will be used for mechanically cleaning wounds and for moistening and lubricating absorbent wound dressings for ulcers, first and superficial second-degree burns, post- surgical wounds and abrasions. The mechanical action of moving across the wound provides for the mechanism of action and aids in the removal of foreign material such as dirt, debris, and microorganisms. It will be provided in non-sterile form, labeled for single patient, single use only.
The device will be available as both a Rx and OTC product.
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(210 days)
Puracyn® Plus Antimicrobial Irrigation Solution is applied with irrigation for mechanical cleansing and removal of debris from wounds, including microorganisms.
Puracyn® Plus Antimicrobial Irrigation Solution is a wound irrigation formula that contains hypochlorous acid as an antimicrobial preservative to inhibit the growth of microorganisms within the solution. The mechanical action of the solution moving across the wound, combined with the hydrodynamic shear provided by mechanical irrigation, aids in the removal of debris and contaminants such as dirt, debris, and microorganisms.
Puracyn® Plus Antimicrobial Irrigation Solution is supplied sterile in 1000 mL and 3000 mL flexible LLDPE bag configurations. Each bag is packaged in a sealed foil pouch.
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(162 days)
Enhanced silver gelling fiber dressing (OTC) may be used for the management of:
- Abrasions
- Lacerations;
- Minor cuts;
- Minor scalds and burns.
Extra enhanced silver gelling fiber dressing (Rx only) may be used for the management of:
- Partial thickness (superficial second degree) burns;
- Diabetic foot ulcers, leg ulcers, (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness);
- Surgical wounds left to heal by secondary intention such as dehisced surgical incisions;
- Surgical wounds that heal by primary intent such as dermatological and surgical incisions(e.g., orthopedic and vascular);
- Traumatic wounds;
- Wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites;
Enhanced silver gelling fiber dressing (OTC)/Extra Enhanced Silver Gelling Fiber Dressing (Prescription) is a soft, conformable, sterile dressing composed of sodium carboxymethyl cellulose fibers, strengthening layer (polyester), 1.2% (w/w) ionic silver, and stitched with enhance fibers (polyester). This conformable dressing absorbs wound fluid and creates a soft gel, provides a moist wound healing environment, and release silver ions within the dressing in the presence of wound fluid to help reduce bacteria within the dressing. Based on in-vitro testing, the silver in the dressing inhibits bacterial growth in the dressing for up to seven days.
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(260 days)
Prescription Use:
LUOFUCON® Skin and Wound cleanser is intended for cleaning wounds and for moistening and lubricating absorbent wound dressings for ulcers, burns, post-surgical wounds and abrasions.
OTC Use:
LUOFUCON® Skin and Wound cleanser is intended for cleaning wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations and minor burns.
LUOFUCON® Skin and Wound Cleanser is a clear, colorless solution with a mild odor. It helps in the mechanical removal of debris and foreign materials from the skin, wounds, or application sites. This product contains 0.1% w/w polyhexamethylene biguanide (PHMB) as a preservative, which helps inhibit the growth of microorganisms in the solution.
LUOFUCON® Skin and Wound Cleanser is available in various packaging forms, such as Spray, Mist, Squeeze, and Bottle models. They can be suited for different clinical situations.
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