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510(k) Data Aggregation
K Number
K171191Device Name
Hexagen Derm
Manufacturer
Global Health Solutions, LLC
Date Cleared
2017-08-25
(123 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Global Health Solutions, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hexagen Derm is a topical emulsion to be used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatoses, including atopic dermatitis, and radiation dermatiis. Hexagen Derm helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Device Description
Hexagen Derm is an amorphous, odorless, petrolatum-based emollient consisting of petrolatum (95%), water, and the antimicrobial preservatives Polyhexamethylene Biguanide (PHMB) and Benzalkonium Chloride (BZK). Hexagen Derm's petrolatum base locks in moisture at the skin surface to keep wounded skin moist. Hexagen Derm is non-sterile, RX only, and available in 30 and 90 gram low density polyethylene tubes.
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K Number
K160872Device Name
PolyPlex Wound Dressing
Manufacturer
GLOBAL HEALTH SOLUTIONS, LLC
Date Cleared
2016-11-23
(238 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
GLOBAL HEALTH SOLUTIONS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Under the management of a healthcare professional, PolyPlex Wound Dressing is intended for the management of first and second degree burns, venous stasis ulcers, diabetic ulcers, partial and full thickness wounds, donor sites, postsurgical incisions, trauma wounds, and abrasions. It can be used during wound dressing changes to soften encrusted wound dressings.
Device Description
PolyPlex Wound Dressing is an amorphous, odorless, petrolatum-based emulsion intended to maintain a moist environment that is conducive to healing. The product contains the preservatives polyhexamethylene biguanide (PHMB) and benzalkonium chloride (BZK) to prevent microbial colonization within the dressing.
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