FDA.reportPublic FDA data

HYALO GYN Vaginal Hydrating Gel, 10g Tube

Primary DI
M713891223796041
Brand
HYALO GYN Vaginal Hydrating Gel, 10g Tube
Company
FIDIA FARMACEUTICI SPA
Model
379604
Catalog number
379604
Device description
HYALO GYN® is a personal lubricant, for penile and/or 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 condoms: lubricated/nonlubricated latex, lubricated polyurethane, lubricated natural skin.
Published
2016-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUCLubricant, Personal

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K094039000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K094039000HYALO GYNFidia Farmaceutici S.P.A.2010-05-07NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M713891223796041PrimaryHIBCC0

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 Fahrenheit103 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
973-552-2567regulatory@fidiapharma.us

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M71389122179604A15HYALO GYN Vaginal Hydrating Gel, 30g Tube1796041796042016-11-01
M7131797040Hyalo GYN Vaginal Hydrating Gel - Made without Parabens1797041797042021-03-25
M7133797040Hyalo GYN Vaginal Hydrating Gel - Made without Parabens Sample3797043797042021-03-25
M713891220750010HYMOVIS® ONE 32mg/4ml syringe89122-0750-0189122-0750-012025-11-07
M713FID075010HYMOVIS® ONE Professional Sample, 32mg/4ml syringeFID07501FID075012025-11-07
M713FPRP400RICHPLAT ORTHO 40 PRP SYSTEMFPRP40FPRP402025-10-31
M713FPRP200RICHPLAT ORTHO PRP SYSTEMFPRP20FPRP202021-03-25
M713COL2021COL-FID4 Care Collagen Wound DressingCOL202COL2022025-11-24
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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