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
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
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
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
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
10834533001411DG HealthDOLGENCORP, LLCHEB2026-03-23
10834533001442DG HealthDOLGENCORP, LLCHEB2026-03-23
00850068130863Pixie CupPixie Cup LLCHEB2026-03-19
00850068130870Pixie CupPixie Cup LLCHEB2026-03-19
00850068130887Pixie CupPixie Cup LLCHEB2026-03-19
00850068130894Pixie CupPixie Cup LLCHEB2026-03-19
00850068130900Pixie CupPixie Cup LLCHEB2026-03-19
00850068130917Pixie CupPixie Cup LLCHEB2026-03-19
00850068130924Pixie CupPixie Cup LLCHEB2026-03-19
00850068130931Pixie CupPixie Cup LLCHEB2026-03-19
00850068130948Pixie CupPixie Cup LLCHEB2026-03-19
00810152230848Public GoodsDon't Run Out, Inc.HEB2026-03-09
00036000597295U by KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-02-18
30810042482396CoraCoraHEB2026-01-21
20810042482405CoraCoraHEB2026-01-21
20810042482412CoraCoraHEB2026-01-21
20810042482429CoraCoraHEB2026-01-21
00628719704073Iris + ArloIris + Arlo Inc.HEB2026-01-06
00628719704127Iris + ArloIris + Arlo Inc.HEB2026-01-06
00628719704134Iris + ArloIris + Arlo Inc.HEB2026-01-06
00628719704639Iris + ArloIris + Arlo Inc.HEB2026-01-06
00628942539305Iris + ArloIris + Arlo Inc.HEB2026-01-06
00628942539329Iris + ArloIris + Arlo Inc.HEB2026-01-06
00628942539336Iris + ArloIris + Arlo Inc.HEB2026-01-06
00990498500215Iris + ArloIris + Arlo Inc.HEB2026-01-06
00990498500222Iris + ArloIris + Arlo Inc.HEB2026-01-06
00628719704066Iris + ArloIris + Arlo Inc.HEB2026-01-05
00628942539299Iris + ArloIris + Arlo Inc.HEB2026-01-05
10050428273484CVS Health TamponsWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDHEB2025-12-31
40073010720747TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2025-12-19