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510(k) Data Aggregation
K Number
K160095Device Name
Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz
Manufacturer
Simple Science, LLC
Date Cleared
2016-06-10
(143 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Simple Science, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For Over-the-Counter Use: For management of minor skin abrasions, minor lacerations, minor irritations, minor cuts, minor burns and intact skin.
Prescription Use: For management of wounds such as Stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot and leg ulcers, post-surgical wounds, first-and seconddegree burns, grafted and donor sites, and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings.
Device Description
Simple Science Antimicrobial Wound & Skin Cleanser is a clear hypotonic solution topically applied to skin and wound areas. The subject device is a wound management and cleansing solution that is intended for cleansing, irrigating, and debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings (e.g. gauze). The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. Simple Science Antimicrobial Wound & Skin Cleanser contains the following ingredients: Ionized water (99.927%), Sodium chloride (0.06%), Hypochlorous acid (0.011%) and hypochlorite Ion (0.002%). Simple Science Antimicrobial Wound & Skin will be supplied in Polyethylene terephthalate (PET) bottles of various volumes (2 oz, 8 oz, 16 oz, 23 oz) with spray inserts / caps.
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K Number
K142592Device Name
CleanSmart Wound Cleanser
Manufacturer
SIMPLE SCIENCE, LLC
Date Cleared
2015-09-02
(352 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SIMPLE SCIENCE, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Over-the-Counter Use: For management of minor skin abrasions, minor irritations, minor cuts, minor cuts, minor burns and intact skin. Prescription Use: For management of wounds such as Stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot and leg ulcers, post-surgical wounds, first-and second-degree burns, grafted and donor sites, and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings.
Device Description
CleanSmart™ Wound Cleanser is a clear hypotonic solution topically applied to skin and wound areas. The subject device is a wound management and cleansing solution that is intended for cleansing, irrigating, and debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings (e.g. gauze). The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. CleanSmart™ Wound Cleanser contains the following ingredients: Ionized water (99.927%), Sodium chloride (0.06%), Hypochlorous acid (0.011%) and hypochlorite Ion (0.002%). CleanSmart™ Wound Cleanser will be supplied in Polyethylene terephthalate (PET) bottles of various volumes (2 oz, 8 oz, 16 oz, 23 oz) with spray inserts / caps.
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