HYALO GYN Vaginal Moisturizing Suppositories Sample

Basic Information

• Brand Name: HYALO GYN Vaginal Moisturizing Suppositories Sample
• Primary DI: M713100004050
• Version / Model: 10000405
• Catalog Number: 10000405
• Company Name: FIDIA FARMACEUTICI SPA
• Labeler DUNS: 428453013
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-25
• Public Version: 2
• Public Version Date: 2022-11-14
• Public Version Status: Update
• Public Device Record Key: 0f6109b6-81cc-450f-99ab-bbe2f7b93604

Device Description

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. The sample box contains 3 suppositories

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NUC	Lubricant, Personal	Obstetrics/Gynecology	884.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34131	Vaginal lubricant	A non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M713100004050	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 33 – 77 Degrees Fahrenheit