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Device Description

Hyalo GYN Vaginal Moisturizing Suppositories are non-sterile, glyceride-based personal lubricants. The subject lubricant is intended to moisturize and lubricate the vaginal epithelium to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. The Hyalo GYN Vaginal Moisturizing Suppositories are provided in peel-to-open pre-cut strips, in an outer cardboard box with a package insert.

Indications for Use

Hyalo GYN Vaginal Moisturizing Suppositories are personal lubricants 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.
Hyalo GYN Vaginal Moisturizing Suppositories are not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

Principle of Operation / Technology

Hyalo GYN Vaginal Moisturizing Suppositories are personal lubricants 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.

510(k) Number:K191052

Device Name: HyaloGYN Vaginal Moisturizing Suppositorie

Manufacturer:FIDIA FARMACEUTICI SPA

Device Name: HyaloGYN Vaginal Moisturizing Suppositorie

Classification Name:LUBRICANT, PERSONAL

Proprietary Name:Hyalo GYN Vaginal Moisturizing Suppositories

Classification Name:LUBRICANT, PERSONAL

Product Code:NUC

Device Class:2

Regulation Number:884.5300

Medical Specialty:Obstetrics/Gynecology

Registered Establishment Name:FIDIA FARMACEUTICI SPA

Registered Establishment Number:9610200

Premarket Submission Number:K191052

Owner/Operator:Fidia Farmaceutici SPA

Owner/Operator Number:9027294

Establishment Operations:Specification Developer