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510(k) Data Aggregation
K Number
K143444Device Name
SynePure Wound Cleanser
Manufacturer
Synedgen Inc.
Date Cleared
2015-08-21
(262 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Synedgen Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SynePure™ Wound Cleanser is intended for the cleansing and rinsing of dermal wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritations of the skin.
Device Description
SynePure is a biocompatible, cleansing solution that is intended for rinsing and cleansing dermal wounds through irrigation. The solution is preserved and provided in flexible low density polyethylene (LDPE) bottles with a nozzle spray top to allow for easy delivery of a stream of liquid to remove dirt, debris and contamination from a wound. A screw cap is used to secure the device when not in use. The cap/bottle assembly is sealed with a strip to indicate tampering.
The wound cleanser is supplied as 125mL single-use or 250mL multiple-use bottle. The mechanical action of fluid moving across the wound provides for the mechanism of action to aid in the removal of foreign objects, such as dirt and debris, from the wound.
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