FDA.reportPublic FDA data

Vaginal Applicator

Primary DI
00719113275860
Brand
Vaginal Applicator
Company
Mai/Genesis
Model
27586
Catalog number
27586
Device description
Quad-Tip Vaginal Applicator
Published
2023-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HGDApplicator, Vaginal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGDApplicator, VaginalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00719113275860PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00719113275860007191132758607191132758600719113275860

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal applicator, reusableA device designed to apply medication to the vagina. It is typically a hand-held bulb, pump, or injector used to introduce medicated powder or other substances into the vagina either directly or through an open speculum. It is typically used to treat vaginitis but can be used for other forms of vaginal treatment. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078873500
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00683693360004Evert-It36000360002023-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015433701WandahCASCO BAY MOLDING LTD.HGD2026-05-15
00841445001388Diva Biome Balancer ApplicatorDiva International IncHGD2026-02-06
10378206189018XACIATOOrganon LLCHGD2024-09-13
00860012119363ReiaReia, LLCHGD2024-07-22
00860012119370ReiaReia, LLCHGD2024-07-22
00860012119387ReiaReia, LLCHGD2024-07-22
00850016867377Pixie CupPixie Cup LLCHGD2023-11-20
00850016867728Pixie CupPixie Cup LLCHGD2023-11-20
00338779998410Vaginal Suppository ApplicatorMedisca Inc.HGD2023-09-10
00338779998427Vaginal Suppository ApplicatorMedisca Inc.HGD2023-09-10
00338779998434Vaginal Suppository ApplicatorMedisca Inc.HGD2023-09-10
10338779998417Vaginal Suppository ApplicatorMedisca Inc.HGD2023-09-10
10338779998424Vaginal Suppository ApplicatorMedisca Inc.HGD2023-09-10
10338779998431Vaginal Suppository ApplicatorMedisca Inc.HGD2023-09-10
00860009492905VCA LitePce, Inc.HGD2023-08-11
00860009492912VCA LitePce, Inc.HGD2023-08-11
00826804000516Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00826804000523Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00826804000530Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00826804006914Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00826804006938Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00826804006945Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00826804006952Aloe CadabraLive Well Brands, Inc.HGD2023-06-16
00813360022076DoselogixTEAM TECHNOLOGIES, INC.HGD2022-09-07
10813360022073DoselogixTEAM TECHNOLOGIES, INC.HGD2022-09-07
00813360022069DoselogixTEAM TECHNOLOGIES, INC.HGD2022-09-01
00813360021994DoselogixTEAM TECHNOLOGIES, INC.HGD2022-07-30
08057509880031NAINGE SPAHGD2022-07-17
08057509880024NAINGE SPAHGD2022-07-17
00653160055733CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHGD2022-01-02