FDA.reportPublic FDA data

vH Essentials Moisturizing Vaginal Suppositories

Primary DI
M71353960
Brand
vH Essentials Moisturizing Vaginal Suppositories
Company
FIDIA FARMACEUTICI SPA
Model
5396
Device description
vH Essentials Moisturizing Vaginal Suppositories are a non-hormonal moisturizer delivered in an easy-to-use suppository format. vH Essentials Moisturizing Vaginal Suppositories, intended for the temporary relief of vaginal dryness symptoms, moisturize and lubricate the vaginal epithelium 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.
Published
2022-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
NUCLubricant, Personal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUCLubricant, PersonalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M71353960PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal lubricantA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature33 Degrees Fahrenheit77 Degrees Fahrenheit

Regulatory Flags#

DUNS number
428453013
Device count
1
Lot or batch
true
Expiration date on label
true

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M713FPRP400RICHPLAT ORTHO 40 PRP SYSTEMFPRP40FPRP402025-10-31
M713FPRP200RICHPLAT ORTHO PRP SYSTEMFPRP20FPRP202021-03-25
M71389122072412A1Hyalgan® Sodium Hyaluronate 2mL Vial89122-0724-1289122-0724-122015-07-31
M71389122087901A1TriLURONM71389122087901A1389122-0879-012019-11-04
M71389122072420A1Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL89122-0724-2089122-0724-202015-07-31
M713891220879010TRILURON89122-0879-0189122-0879-012024-05-07
M713891220724200Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL89122-0724-2089122-0724-202023-10-16
M713891220724120Hyalgan® Sodium Hyaluronate 2mL Vial89122-0724-1289122-0724-122023-09-13
M71389122049663A16Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe89122-0496-6389122-0496-632016-03-21
M713494290030100Hyalo4 Care Clear Hydrogel, 30g49429-0030-1049429-0030-102023-06-14
M713494290100350Hyalo4 Care Clear Hydrogel, 100g49429-0100-3549429-0100-352023-06-14
M713494440025080Hyalo4 Care Hydrogel, 25g49444-0025-0849444-0025-082023-06-14
M713494440100350Hyalo4 Care Hydrogel, 100g49444-0100-3549444-0100-352023-06-14
M713100004050HYALO GYN Vaginal Moisturizing Suppositories Sample10000405100004052021-03-25

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