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510(k) Data Aggregation
K Number
K161212Device Name
Atteris Antimicrobial Skin Protectant
Manufacturer
ROCHAL INDUSTRIES LLC
Date Cleared
2016-09-30
(155 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ROCHAL INDUSTRIES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Atteris Antimicrobial Barrier Film Dressing is intended for application to minor wounds and damaged skin as a liquid, film forming barrier, which creates a waterproof, film dressing, protecting the wound or damaged skin.
Device Description
Atteris™ Antimicrobial Barrier Film Dressing is a polymeric solution which forms a uniform film when applied to minor wounds and damaged skin. The product is dispersed in a unique non-cytotoxic, non-stinging solution via a standard 28 mL pump spray bottle. The product is biocompatible, non-stinging, fast drying, and has low friction. Antimicrobial Barrier Film Dressing protects minor wounds and damaged skin by providing a secure, breathable, waterproof barrier to external contaminates. The film dressing is colorless, transparent, and possesses good oxygen and moisture vapor permeability. The antimicrobial PHMB at a concentration of 0.001% w/w is added to the product as a preservative to inhibit the growth of microorganisms within the product.
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K Number
K160192Device Name
Atteris Antimicrobial Skin & Wound Cleanser
Manufacturer
ROCHAL INDUSTRIES LLC
Date Cleared
2016-07-28
(183 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ROCHAL INDUSTRIES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
(Rx Only) Atteris Antimicrobial Skin & Wound Cleanser is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds such as stage I-IV pressure ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, grafted and donor sites.
(OTC use) Atteris Antimicrobial Skin & Wound Cleanser is intended for physical cleaning and removal of dirt and debris, from skin scrapes, cuts, lacerations, minor irritations, exit sites and unbroken skin.
Device Description
Atteris Antimicrobial Skin & Wound Cleanser helps in the mechanical removal of debris and foreign material from the skin, wound or application site. Atteris Antimicrobial Skin & Wound Cleanser is a pure, colorless, isotonic cleanser that is safe. The cleanser has a six month expiration due to the preservative that provides bactericidal and fungicidal properties through the action of the antimicrobial (PHMB).
A preservative, PHMB, at a concentration of 0.1% w/w is added to the product to inhibit the growth of microorganisms such as, Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Escherichia coli, antibiotic resistant Methicillin Resistant Staphylococcus aureus (MRSA), and fungus Candida albicans within the product.
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K Number
K160684Device Name
Atteris No-Sting Skin Protectant
Manufacturer
ROCHAL INDUSTRIES LLC
Date Cleared
2016-07-26
(137 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
ROCHAL INDUSTRIES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Atteris No Sting Skin Protectant is intended for application to intact or damaged skin as a liquid, film-forming product, which creates a long-lasting waterproof barrier, protecting the skin from bodily wastes, fluids, add friction. It is intended as a primary barrier against irritation from body fluids.
Device Description
Atteris No Sting Skin Protectant is a polymeric solution which forms a uniform film when applied to the skin. The product is biocompatible, non-stinging, and fast drying. Atteris No Sting Skin Protectant shields intact or damaged skin from irritation caused by bodily fluids, wound drainage, adhesives, and friction. The film is colorless, transparent, and possesses good oxygen and moisture vapor permeability. Atteris No Sting Skin Protectant will be supplied in a High Density Polyethylene (HDPE) bottle with pump spray cap.
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