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Found 3 results
510(k) Data Aggregation
K Number
K100839Device Name
BARIREP
Manufacturer
GORBEC PHARMACEUTICAL SERVICES, INC.
Date Cleared
2010-05-11
(48 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
GORBEC PHARMACEUTICAL SERVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BariRep's intended use is to manage minor burns, minor abrasions, minor cuts and minor lacerations.
Device Description
BariRep is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for over-the-counter use. The product is formulated as an oil-inwater emulsion containing a cross-linked polyacrylic acid polymer, natural gum, and cellulose as thickening agents. The oil composition of BariRep is composed of glyceride, squalane, lecithin, and fatty acids.
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K Number
K082865Device Name
MODIFICATION TO ZENIEVA
Manufacturer
GORBEC PHARMACEUTICAL SERVICES, INC.
Date Cleared
2008-10-23
(24 days)
Product Code
NAE
Regulation Number
878.4022Why did this record match?
Applicant Name (Manufacturer) :
GORBEC PHARMACEUTICAL SERVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Zenieva is used to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis, and allergic contact dermatitis. Zenieva helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Device Description
Zenieva is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for prescription (requires a physician diagnosis of disease state) use. The product is formulated as an oil-in-water emulsion containing a crosslinked polyacrylic acid polymer, natural gum, and cellulose as thickening agents. The oil composition of Zenieva is composed of glyceride, squalane, lecithin, and fatty acids.
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K Number
K073246Device Name
ZENIEVA
Manufacturer
GORBEC PHARMACEUTICAL SERVICES, INC.
Date Cleared
2008-07-23
(247 days)
Product Code
NAE
Regulation Number
878.4022Why did this record match?
Applicant Name (Manufacturer) :
GORBEC PHARMACEUTICAL SERVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Zenieva is used to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis, and allergic contact dermatitis. Zenieva helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Device Description
Zenieva is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for prescription (requires a physician diagnosis of disease state) use. The product is formulated as an oil-in-water emulsion containing a crosslinked polyacrylic acid polymer, natural gum, and cellulose as thickening agents. The oil composition of Zenieva is composed of glyceride, squalane, lecithin, and fatty acids.
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