Search Results
Found 1 results
510(k) Data Aggregation
K Number
K152533Device Name
Xonrid Gel
Manufacturer
Date Cleared
2016-10-28
(421 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Helsinn Healthcare SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Under the supervision of a healthcare professional, Xonrid® Gel is indicated to manage and relieve the burning and itching experienced with radiation dermatitis. Xonrid® Gel helps to relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process. Not intended to be used on open wounds.
Device Description
Xonrid® Gel is a multi-component prescription medical device product. It is a non-sterile topical water-based gel that forms a protective barrier on skin to increase moisture and reduce water loss. Xonrid® Gel contains numerous ingredients that are grouped into several common ingredient classes, including emollients; preservatives; skin conditioning agents; viscosity-increasing agents; emulsifying agents; and binders. Each ingredient is a wellrecognized component of topical cosmetic products that primarily provide the skin conditioning and emollient features of Xonrid® Gel. Xonrid® Gel provides a physical, topical barrier to the skin. The product is packaged in a 75 mL bottle equipped with an airless dispensing system and a cap. The bottle is manually operated, with each pump administering approximately 240 ul of product.
Ask a Question
Ask a specific question about this device
Page 1 of 1