FDA.reportPublic FDA data

XACIATO

Primary DI
10378206189018
Brand
XACIATO
Company
Organon LLC
Model
1048228
Published
2024-09-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
10378206189018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1037820618901810378206189018

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal applicator, single-useA device designed to apply medication to the vagina. It is typically a simple rod, blade, spatula, or paddle. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight5Gram

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)674-3200dpoc.us@organon.com

Regulatory Flags#

DUNS number
117494753
Device count
1
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840164519440FOLLISTIM PEN STARTER KIT10449422024-01-01
00840164519457FOLLISTIM PEN STARTER KIT SAM10449432024-01-01
00378206129017FOLLISTIM AQ CARTRIDGE 300IU10446152024-01-01
00378206129598FOLLISTIM AQ CARTRIDGE 300IU SAM10448012024-01-01
00378206130013FOLLISTIM AQ CARTRIDGE 600IU10446162024-01-01
00378206130594FOLLISTIM AQ CARTRIDGE 600IU SAM10448002024-01-01
00378206131010FOLLISTIM AQ CARTRIDGE 900IU10446172024-01-01
60378206129019FOLLISTIM AQ CARTRIDGE 300IU10446152024-01-01
60378206129590FOLLISTIM AQ CARTRIDGE 300IU SAM10448012024-01-01
60378206130015FOLLISTIM AQ CARTRIDGE 600IU10446162024-01-01
60378206130596FOLLISTIM AQ CARTRIDGE 600IU SAM10448002024-01-01
60378206131012FOLLISTIM AQ CARTRIDGE 900IU10446172024-01-01
60840164519442FOLLISTIM PEN STARTER KIT10449422024-01-01
60840164519459FOLLISTIM PEN STARTER KIT SAM10449432024-01-01
00840164521139JADA SystemJADA-20022023-02-15
60840164521131JADA SystemJADA-20022023-02-15

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
00860012119363ReiaReia, LLCHGD2024-07-22
00860012119370ReiaReia, LLCHGD2024-07-22
00860012119387ReiaReia, LLCHGD2024-07-22
00850016867377Pixie CupPixie Cup LLCHGD2023-11-20
00850016867728Pixie CupPixie Cup LLCHGD2023-11-20
00719113275860Vaginal ApplicatorMai/GenesisHGD2023-09-14
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