FDA.reportPublic FDA data

TOP The Organic Project

Primary DI
20855212008047
Brand
TOP The Organic Project
Company
TOP The Organic Project
Model
Organic Cotton, Bio Based Applicator Tampon - Ligh
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
20855212008047PackageGS112In Commercial Distribution
00855212008098PrimaryGS10
00855212008043Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085521200804720855212008047
00855212008098008552120080988552120080980855212008098
00855212008043008552120080438552120080430855212008043

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
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
00855212008128Top The Organic ProjectOrganic Cotton Bio Based Applicator Tampon - Super2019-10-31
10860495001336TOPCardboard Applicator Regular 2018-03-27
10860495001343TOPCardboard Applicator Super 2018-03-27
00860495001360TOPSample pack 2018-05-11

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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
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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
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