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510(k) Data Aggregation
(268 days)
Rx:
Under the supervision of a healthcare professional, MiraChlorTM Wound Cleanser Solutions is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material and debris from exudating wounds, acute and chronic dermal lesions including stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, partial-thickness wounds, first- and superficial second-degree burns, abrasions of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites. It is also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds.
OTC:
MiraChlorTM Wound Cleanser Solutions is intended for OTC use in the management of minor skin abrasions, minor lacerations, minor cuts, and intact skin.
MiraChlorTM Wound Cleanser Solutions are saline based wound cleansers that contain hypochlorous acid as a preservative that inhibits microbial contamination within the solution while on the shelf. MiraChlorTM Wound Cleanser Solutions create a moist environment and remove slough and other foreign materials from the wound bed. As a result of mechanical action of solution moving across the wound bed, dirt, and debris, are removed. Moistening and cleansing a wound, such as by using MiraChlorTM Wound Cleanser Solutions.
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