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510(k) Data Aggregation
K Number
K203377Device Name
VR101 Lubricating Intravaginal Ring
Manufacturer
J3 Bioscience, Inc.
Date Cleared
2021-05-20
(184 days)
Product Code
QPD
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
J3 Bioscience, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VR101 Lubricating Intravaginal Ring is a personal 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 and synthetic (polyurethane and polyisoprene) male condoms and FC2 female condoms.
Device Description
The VR101 Lubricating Intravaginal Ring device is a lubricating intravaginal ring designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. VR101 Lubricating Intravaginal Ring is constructed from a hollow biomedical grade hydrophilic polyether urethane (HPU) tube filled with a liquid vaginal lubricating solution comprised of a solution of glycerol (also known as glycerin), water, and sodium chloride. Upon insertion of VR101 Lubricating Intravaginal Ring in the vagina, the lubricating solution in the lumen ring is released through the semi-permeable wall of the tubing into the vagina, moisturizing and lubricating the vaginal mucosa without the use of any hormones or active pharmaceutical ingredients (APIs).
Each VR101 Lubricating Intravaginal Ring provides moisturization and lubrication for up to seven (7) days.
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