FDA.reportPublic FDA data

REVAREE

Primary DI
08032595871071
Brand
REVAREE
Company
FARMA DERMA SRL
Model
VAGINAL SUPPOSITORIES 2 g
Published
2018-02-26
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
K153372000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153372000Repagyn vaginal suppositoriesFarma-Derma S.R.L.2016-06-30NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08032595871071PrimaryGS10
08032595871088Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08032595871071080325958710718032595871071
08032595871088080325958710888032595871088

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal mucosa protection suppositoryA device in the form of a tablet, ovule or gel that is inserted into the vagina containing compounds [e.g., hyaluronic acid (HA), plant oil extracts, vitamins] intended to promote and/or expedite the healing, re-epithelialization, and/or soothing of injured, atrophic, or irritated vaginal mucosa through various mechanisms (e.g., osmotic properties, lubrication). It is typically used for procedure-related injury (e.g., after childbirth, surgery, radiation), age-related dryness, or various pathologies (e.g., vulvovaginitis). It is intended for use in the home or healthcare facility. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
541677746
Device count
3
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08032595872429REVAREEVAGINAL SUPPOSITORIES 2G2025-06-26
08032595872436REVAREEVAGINAL SUPPOSITORIES 2G2025-06-26
08032595871088REVAREEVAGINAL SUPPOSITORIES 2G2025-06-26
08032595872078REVAREE PLUS VAGINAL SUPPOSITORIES 2G2024-03-27
08032595871941REVAREE PLUS VAGINAL SUPPOSITORIES 2G2023-10-02
08032595871958REVAREE PLUS VAGINAL SUPPOSITORIES 2G2023-10-02
08032595871064REVAREE VAGINAL SUPPOSITORIES 2 g2018-02-26

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