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 IDM713100004040
NIH Device Record Key6bfe754f-e467-491e-ac3d-a67da88caa4f
Commercial Distribution StatusIn Commercial Distribution
Brand NameHYALO GYN Vaginal Moisturizing Suppositories
Version Model Number10000404
Catalog Number10000404
Company DUNS428453013
Company NameFIDIA FARMACEUTICI SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us
Phone973-577-6202
Emailregulatory@fidiapharma.us

Operating and Storage Conditions

Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 33 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM713100004040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NUCLubricant, Personal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-02
Device Publish Date2021-03-25

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