Search Results
Found 2 results
510(k) Data Aggregation
K Number
K193444Device Name
Vagisan MoistCream Cremolum
Manufacturer
Date Cleared
2020-12-04
(358 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
**Dr. August Wolff GmbH **& Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Vagisan MoistCream Cremolum is a personal lubricant, a suppository for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex condoms and synthetic (polyurethane and polyisoprene) condoms.
Device Description
The Vagisan MoistCream Cremolum is a ready-to-use, non-sterile, glycerin-based personal lubricant suppository for intravaginal application that melts after digital insertion to form a smooth cream. The device is intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Vagisan MoistCream Cremolum consists of hydrogenated coco-glycerides, ceteary1 alcohol, lactic acid, calcium lactate, PEG-20 glyceryl stearate, and sodium carbomer. Each vaginal suppository is individually packaged in a foil blister pack, which are sold in boxes of eight or 16 vaginal suppositories.
Ask a Question
Ask a specific question about this device
K Number
K152507Device Name
Dr. Wolff Vagisan Moisturising Cream
Manufacturer
Date Cleared
2016-05-20
(261 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
**DR. AUGUST WOLFF GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Vagisan® Moisturizing Cream is a personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex condoms and synthetic (polyurethane and polyisoprene) condoms.
Device Description
Vagisan Moisturizing Cream is a non-sterile, water-based, white, non-irritating, non-greasy, non-staining vaginal cream delivered in a tube with a reusable applicator or sachet (sample size) as a long-lasting moisturizer for vaginal dryness.
Ask a Question
Ask a specific question about this device
Page 1 of 1