FDA.reportPublic FDA data

TOP

Primary DI
00860495001360
Brand
TOP
Company
TOP The Organic Project
Model
Sample pack
Device description
Sample pack contains: - Ultra Thin Organic Cotton Pad with Wings,1 unit - Ultra Thin Organic Cotton Liner, 1 unit - Organic Cotton Applicator Tampon Regular, 1 unit
Published
2018-05-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
10860495001367PackageGS130In Commercial Distribution
00860495001360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086049500136710860495001367
00860495001360008604950013608604950013600860495001360

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
1
Lot or batch
true

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
10855212008064TOP The Organic ProjectOrganic Cotton Bio Based Applicator Tampon - Regul2019-10-31
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
06972465050002Borage MedicalSuzhou Borage Medical Technology Co.,Ltd.HEB2026-10-10
06972465050309Borage MedicalSuzhou Borage Medical Technology Co.,Ltd.HEB2026-10-10
06972465050323Borage MedicalSuzhou Borage Medical Technology Co.,Ltd.HEB2026-10-09
06972465050361Borage MedicalSuzhou Borage Medical Technology Co.,Ltd.HEB2026-10-09
05060994741759DayeTAMPON INNOVATIONS LTD OODHEB2026-10-07
05060994741766DayeTAMPON INNOVATIONS LTD OODHEB2026-10-07
05060994741773DayeTAMPON INNOVATIONS LTD OODHEB2026-10-07
05060994741780DayeTAMPON INNOVATIONS LTD OODHEB2026-10-07
08806011638117Dong-A Pharmaceutical Co., Ltd.Dong-A Pharmaceutical Co., Ltd.HEB2026-09-29
05060994740752DayeTAMPON INNOVATIONS LTD OODHEB2026-09-25
05060994740769DayeTAMPON INNOVATIONS LTD OODHEB2026-09-25
00036000602579KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602586KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602593KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602609KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602616KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602647KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602654KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602661KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000606126KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00073010720091TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010720831TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721173TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721210This is LPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721227TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721272TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721333This is LPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721340TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721517This is LPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721524This is LPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25