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510(k) Data Aggregation
K Number
K181428Device Name
Clyra Wound Irrigation Solution
Manufacturer
Clyra Medical Technologies Inc.
Date Cleared
2019-09-20
(476 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Clyra Medical Technologies Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rx: Clyra Wound Irrigation Solution is intended for use by healthcare professionals for cleansing, moistening and debriding to remove wound debris from acute and chronic dermal lesions that are partial or full thickness wounds such as 1st and 2nd degree burns, stage I - IV pressure ulcers, stasis ulcers, abrasions and minor skin irritations, post surgical wounds, grafted and donor sites, in addition to moistening absorbent wound dressings.
Device Description
Clyra Wound Irrigation Solution 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 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. Clyra Wound Irrigation Solution will be supplied in food grade 4 oz. plastic PET bottles with spray inserts and caps. Clyra Wound Irrigation contains Potassium Iodide and Copper Sulphate, which release iodine when combined, resulting in a concentration within the product of 250 parts per million (ppm). The iodine acts as a preservative to inhibit contamination within the solution.
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