FDA.reportPublic FDA data

REVAREE

Primary DI
08032595872429
Brand
REVAREE
Company
FARMA DERMA SRL
Model
VAGINAL SUPPOSITORIES 2G
Device description
THE PRODUCT IS PACKAGING WITH AND WITHOUT BUNDLING
Published
2025-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08032595872429PrimaryGS10
08032595871088Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08032595872429080325958724298032595872429
08032595871088080325958710888032595871088

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal mucosa protection dressingA substance (e.g., gel, cream, suppository) containing various compounds [e.g., hyaluronic acid (HA), plant oil extracts] intended to be applied in and around the vagina to: 1) promote and/or expedite the healing, re-epithelialization, and/or soothing/lubrication of dry, injured, atrophic, or irritated vaginal mucosa; and/or 2) function as barrier to prevent adherence of pathogenic microorganisms (especially mycotic) to the vulvo-vaginal mucosa. It is intended for use in the home or healthcare facility to manage procedure-related injury (e.g., childbirth, surgery, radiotherapy), menopause, or various pathologies (e.g., vulvovaginitis). After application, this device cannot be reused.

Regulatory Flags#

DUNS number
541677746
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
08032595871071REVAREEVAGINAL SUPPOSITORIES 2 g2018-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08887500730017SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08887500730024SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08887500730031SuperSlydeICM PHARMA PTE. LTD.NUC2026-04-29
08859798108090LIFESTYLESSURETEX LIMITED - BRANCHNUC2026-01-27
20011509061328VagisilCombe IncorporatedNUC2026-01-26
00067981089127KY Personal Lubricant JellyRB Health (us) LLCNUC2025-12-09
00067981089486KY Warming Jelly RB Health (us) LLCNUC2025-12-09
00067981952292KY Intense Pleasure GelRB Health (us) LLCNUC2025-12-09
00067981993691KY Personal Lubricant JellyRB Health (us) LLCNUC2025-12-09
00067981993738KY Personal Lubricant JellyRB Health (us) LLCNUC2025-12-09
00067981993967KY Natural Feeling with Hyaluronic AcidRB Health (us) LLCNUC2025-12-09
00067981993974KY Natural Feeling with Hyaluronic AcidRB Health (us) LLCNUC2025-12-09
00067981993981KY Natural Feeling with Aloe Vera LubricantRB Health (us) LLCNUC2025-12-09
30726893210043One MoveGLOBAL PROTECTION CORP.NUC2025-11-13
00016169700057Nauox Yin YangMAYER LABORATORIES, INC.NUC2025-10-06
00016169700064Nauox Holy HoneyMAYER LABORATORIES, INC.NUC2025-10-06
00016169700071Nauox Dulce DreamsMAYER LABORATORIES, INC.NUC2025-10-06
00016169700088Nauox Sweet HavenMAYER LABORATORIES, INC.NUC2025-10-06
00016169700095Naoux Agave NectarMAYER LABORATORIES, INC.NUC2025-10-06
00016169700194Femme GlydeMAYER LABORATORIES, INC.NUC2025-10-06
00198715811087Kindra V LubeMAYER LABORATORIES, INC.NUC2025-10-06
07964944077692LubeLife - Water-based 8oz - Retail - 3pkCC Wellness LLCNUC2025-07-22
07964944078996LubeLife - Strawberry 8oz - Retail - 3pkCC Wellness LLCNUC2025-07-22
00067981993783K-Y® Hydrablend RB Health (us) LLCNUC2025-07-10
08032595872436REVAREEFARMA DERMA SRLNUC2025-06-26
08859798106058LIFESTYLESSURETEX LIMITED - BRANCHNUC2025-06-18
00067981994155KY Warming Liquid LubricantRB Health (us) LLCNUC2025-06-01
00067981994162KY Yours & Mine Couples LubricantRB Health (us) LLCNUC2025-06-01
00050428111291CVS Mess free liquidGLOBAL PROTECTION CORP.NUC2025-01-06
00050428164655CVS personal lubricant Liquid (5.6oz)GLOBAL PROTECTION CORP.NUC2025-01-06