Satisfaite

Primary DI
00860000221511
Brand
Satisfaite
Company
FEMMEPHARMA CONSUMER HEALTHCARE LLC
Model
01
Catalog number
01
Device description
"Satisfaite vaginal moisturizer and personal lubricant is a non-sterile, water-based, white to off-white, non-irritating, non-greasy, non-staining low volume gel delivered in a single use disposable applicator for vaginal dryness. The applicator provides convenience and provides for less mess during application. Satisfaite is intended for ongoing use, not exclusively for use during intimate sexual activity. Satisfaite contains ingredients commonly used in other products for intravaginal use sold as medical devices and cosmetics. All ingredients used are approved high quality pharmaceutical grade, and considered ""generally recognized as safe for their intended use"" by the FDA. The quantitative formulation is considered confidential commercial information."
Published
2020-06-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K190752000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190752000SatisfaiteFemmepharma Consumer Healthcare, LLC2019-12-13NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860000221511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860000221511008600002215118600002215110860000221511

GMDN Terms#

Term, Definition table
TermDefinition
Sexual lubricantA substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
116647151
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850035529003Mia Vita01012022-11-16

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