FDA.reportPublic FDA data

TOP The Organic Project

Primary DI
10855212008064
Brand
TOP The Organic Project
Company
TOP The Organic Project
Model
Organic Cotton Bio Based Applicator Tampon - Regul
Published
2019-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HEBTampon, Menstrual, Unscented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HEBTampon, Menstrual, UnscentedObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10855212008064PackageGS112In Commercial Distribution
00855212008067PrimaryGS10
00855212008050Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085521200806410855212008064
00855212008067008552120080678552120080670855212008067
00855212008050008552120080508552120080500855212008050

GMDN Terms#

Term, Definition table
TermDefinition
Menstrual tampon, unscentedA non-sterile, non-deodorized plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual or other vaginal discharge. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081106256
Device count
16
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855212008067TOP The Organic ProjectOrganic Cotton Bio Based Applicator Tampon - Regul2019-10-31
00855212008081TOP The Organic ProjectOrganic Cotton Bio Based Applicator Tampon - Super2019-10-31
00855212008098TOP The Organic ProjectOrganic Cotton, Bio Based Applicator Tampon - Ligh2019-10-31
00855212008135Top The Organic ProjectOrganic Cotton Bio Based Applicator Tampon - Super2019-10-31
00860495001339TOPCardboard Applicator Regular 2018-03-27
00860495001346TOPCardboard Applicator Super 2018-03-27
10855212008002TOP Carboard Applicator Regular - BULK 2019-01-23
10855212008019TOPCardboard Applicator Super - Bulk 2019-01-23
00860495001360TOPSample pack 2018-05-11
00855212008104TOP The Organic ProjectOrganic Cotton Bio Based Applicator Tampon - Super2019-10-31
20855212008047TOP The Organic ProjectOrganic Cotton, Bio Based Applicator Tampon - Ligh2019-10-31
00855212008128Top The Organic ProjectOrganic Cotton Bio Based Applicator Tampon - Super2019-10-31
10860495001336TOPCardboard Applicator Regular 2018-03-27
10860495001343TOPCardboard Applicator Super 2018-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00036000586329U by KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-02-18
00036000596168U by KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-02-18
10198926000307BIOPURE Quest USA Corp.HEB2025-03-01
10198926000314BIOPURE Quest USA Corp.HEB2025-03-01
10198926000338BIOPURE Quest USA Corp.HEB2025-03-01
10198926000352BIOPURE Quest USA Corp.HEB2025-03-01
09336798002249MoxieThe trustee for Millie & More Unit TrustHEB2025-02-06
00030772162217TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2024-08-07
00032251911798Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911804Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911842Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911859Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911866Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911873Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911880Family WellnessFamily Dollar StoresHEB2024-07-08
00032251911897Family WellnessFamily Dollar StoresHEB2024-07-08
09421904034037OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034044OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034051OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034433OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034440OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034457OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034495OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034501OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
09421904034921OiORGANIC INITIATIVE CORPORATIONHEB2023-12-20
10075289065009Comfort PlusTRANZONIC COMPANIES, THEHEB2023-06-12
10075289064965Comfort PlusTRANZONIC COMPANIES, THEHEB2022-12-30
10075289064941Comfort PlusTRANZONIC COMPANIES, THEHEB2022-11-14
10075289064958Comfort PlusTRANZONIC COMPANIES, THEHEB2022-11-14
10075289064972Comfort PlusTRANZONIC COMPANIES, THEHEB2022-11-14