HYALO GYN Vaginal Moisturizing Suppositories 10000404

GUDID M713100004040

HyaloGYN 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. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The suppositories are made without parabens.

FIDIA FARMACEUTICI SPA

Vaginal lubricant

• Primary Device ID: M713100004040
• NIH Device Record Key: 6bfe754f-e467-491e-ac3d-a67da88caa4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HYALO GYN Vaginal Moisturizing Suppositories
• Version Model Number: 10000404
• Catalog Number: 10000404
• Company DUNS: 428453013
• Company Name: FIDIA FARMACEUTICI SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us
• Phone: 973-577-6202
• Email: regulatory@fidiapharma.us

Operating and Storage Conditions

• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M713100004040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191052

FDA Product Code

• NUC: Lubricant, Personal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-02
• Device Publish Date: 2021-03-25

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