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510(k) Data Aggregation
K Number
K101098Device Name
REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 83035
Manufacturer
LIL DRUG STORE PRODUCTS, INC.
Date Cleared
2010-08-17
(119 days)
Product Code
NUC, MMS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
LIL DRUG STORE PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Replens 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 compatible with natural rubber latex condoms and synthetic (polyurethane and polyisoprene) condoms.
Device Description
Replens Vaqinal Moisturizer is a non-sterile, water-based, white to off-white, non-irritating, non-greasy, non-staining vaginal gel delivered in a tube with a reusable applicator as a long-lasting moisturizer for vaginal dryness. The use of the reusable applicator provides less mess in application. Replens Vaginal Moisturizer is intended for ongoing use, not exclusively for use during intimate sexual activity.
Replens Vaginal Moisturizer contains ingredients commonly used in other products for vaginal use sold as medical devices and cosmetics. All ingredients are either NF, USP, or are considered "generally recognized as safe for their intended use". The quantitative formulation is considered confidential commercial information.
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K Number
K101241Device Name
REPLENS LONG-LASTING VAGINAL MOISTURIZER (PRE-FILLED APPLICATOR)
Manufacturer
LIL DRUG STORE PRODUCTS, INC.
Date Cleared
2010-08-17
(105 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
LIL DRUG STORE PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Replens 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 compatible with natural rubber latex condoms and synthetic (polyurethane and polyisoprene) condoms.
Device Description
Replens Vaginal Moisturizer is a non-sterile, water-based, white to off-white, non-irritating, non-greasy, non-staining vaginal gel delivered in single-use, pre-filled applicators as a long-lasting moisturizer for vaginal dryness. The use of prefilled applicators provides less mess in application. Replens Vaginal Moisturizer is intended for ongoing use, not exclusively for use during intimate sexual activity.
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K Number
K072414Device Name
CRYOSTAT
Manufacturer
LIL DRUG STORE PRODUCTS, INC.
Date Cleared
2008-04-07
(223 days)
Product Code
LKX
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
LIL DRUG STORE PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is for the treatment of external hemorrhoids by applying cold therapy (cryotherapy) directly to swollen hemorrhoidal veins. By applying the device to the tissue, the inflammation is reduced. The direct application of cold provides prompt relief of/extinguishes itching, burning, pain, and swelling. In addition, the device is beneficial for the treatment of perianal fissures due to the vasoconstriction and analgesia properties of the device.
Device Description
The Cryostat Cold Therapy Pack device consists of a combination of water and chemicals in an anatomically designed sealed plastic bag, enclosed in a cloth outer wrapper for comfort. Six Cold Therapy Packs are packaged in one carton. An individual cold pack is 95mm long and 25mm wide and 26mm in depth. A cold pack consists of a series of inner plastic containers, one of which contains water and FDA food grade dye (to distinguish it from the other fluid), inside a second container which contains a secondary fluid, consisting of water, USP Food grade Kosher propylene glycol as well as a different color FDA food grade dye. The freezing temperature of the first fluid is higher than that of the second fluid. This allows a time released cooling process which delivers high performance cold therapy because of conduction and convection following the phase change of the primary fluid from solid to liquid. The containers are made of formable film common in the food and medical packaging industry. The film is a multi-layer extrusion with one layer being Nylon to add strength and act as a vapor barrier. Visual inspection is performed to verify seal integrity and the dye in the fluids facilitates quality control. Since the intended use of the device is to treat a specific ailment which requires comfort, the miniature cold pack is then wrapped in a heat sealable fabric for comfort to the affected area. The material chosen is white, so that the device, once used can be seen as soiled and therefore is disposed of.
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