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510(k) Data Aggregation
K Number
K193336Device Name
Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse
Manufacturer
Date Cleared
2020-05-27
(177 days)
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Synedgen, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Synvaza manages the pain in many types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa. It adheres to oral tissue and forms a protective barrier between the wound and contamination. It provides the moist wound environment required for optimal wound healing. Manages pain associated with oral wounds, mouth sores, injuries and ulcers of the mouth such as: canker sores, irritation and traumatic ulcers.
Device Description
Synvaza is an oral wound rinse specifically formulated with moisturizers, humectants, and mucoadhesive biopolymers that are designed to manage the pain in many types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa. When swished around the mouth, the mucoadhesive formulation results in a temporary formation of a protective coating over the oral mucosa. The liquid also provides a moist wound environment, which is required for optimal wound healing. Synvaza is supplied in plastic bottles with and without a hand pump.
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K Number
K172338Device Name
Catasyn Advanced Technology Wound Hydrogel
Manufacturer
Date Cleared
2018-02-21
(203 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Synedgen, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Catasyn OTC is indicated for the dressing and management of minor burns, minor cuts, minor lacerations, minor abrasions, and minor irritations of the skin.
Catasyn RX may be used under the direction of a health care professional for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-operative incisions and donor sites) and superficial and partial thickness (second degree) burns.
Device Description
Catasyn is a clear, colorless hydrogel that is composed of hypromellose, arginine derivatized chitosan, betaine, and methylparaben to form a hydrogel dressing. The device is a non-sterile, preserved hydrogel. The gel is supplied in 0.07oz. (2mL), 0.85oz (25mL), or 3oz (88.7mL) tubes.
Catasyn is a wound hydrogel that provides a moist wound environment. A moist wound environment is supportive to wound healing.
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