HYALO GYN Vaginal Hydrating Gel, 10g Tube - Made without Parabens Sample 379704

GUDID M7133797040

HYALO GYN® Made without parabens 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 polyisoprene condoms.

FIDIA FARMACEUTICI SPA

Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant

• Primary Device ID: M7133797040
• NIH Device Record Key: 76961b24-c13c-4b8e-af17-4051a9131f19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HYALO GYN Vaginal Hydrating Gel, 10g Tube - Made without Parabens Sample
• Version Model Number: 379704
• Catalog Number: 379704
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 103 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 103 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 103 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 103 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 103 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 103 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 103 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 103 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 103 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 103 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 103 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 103 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 103 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 103 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 103 Degrees Fahrenheit
• Storage Environment Temperature: Between 33 Degrees Fahrenheit and 103 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7133797040 [Primary]

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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