FDA.reportPublic FDA data

Handy Solutions

Primary DI
00024291290438
Brand
Handy Solutions
Company
Navajo Manufacturing Company
Model
29043
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HEBTampon, Menstrual, Unscented

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023479000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023479000FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGESFirst Quality Hygienic, Inc.2002-11-26HEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00024291290438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00024291290438000242912904380242912904380024291290438

GMDN Terms#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
091917799
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00024291256076HANDY SOLUTIONS HEATING PAD WRAP SHOULDER AND NECK256072026-01-29
00024291257561Handy Solutions257562025-09-30
00024291312321Handy Solutions31232312322025-09-30
00024291261025Handy Solutions261022016-08-31
00024291261032Handy Solutions261032016-08-31
00024291261049Handy Solutions261042016-08-31
00024291262800Handy Solutions261032016-08-31
00024291262817Handy Solutions261042016-08-31
10024291261022Handy Solutions261022016-08-31
10024291261039Handy Solutions261032016-08-31
10024291261046Handy Solutions261042016-08-31
20024291261029Handy Solutions261022016-08-31
20024291261036Handy Solutions261032016-08-31
20024291261043Handy Solutions261042016-08-31
20024291262804Handy Solutions261032016-08-31
20024291262811Handy Solutions261042016-08-31
00024291309017Handy Solutions309012024-02-05
00024291261193Handy Solutions261192016-08-31
00024291262824Handy Solutions261192016-08-31
10024291261190Handy Solutions261192016-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195893628032Organic Light Tampons-8ctTPC Inc.HEB2026-05-28
00195893724130Organic Super Tampons-8ctTPC Inc.HEB2026-05-28
00195893932832Organic Regular Tampons-8ctTPC Inc.HEB2026-05-28
00196852297061Organic Light Tampons-16ct Original PackagingTPC Inc.HEB2026-05-28
00196852637379Organic Super Tampons-16ct Original PackagingTPC Inc.HEB2026-05-28
00196852929245Organic Regular Tampons-16ct Original PackagingTPC Inc.HEB2026-05-28
00860010723173Organic Regular Tampons-550ctTPC Inc.HEB2026-05-28
00860012610303Organic Regular and Super Tampons-16ctTPC Inc.HEB2026-05-28
00860012610310Organic Regular Tampons-16ctTPC Inc.HEB2026-05-28
00860013110925Organic Super Tampons-16ctTPC Inc.HEB2026-05-28
00860013110932Organic Light Tampons-16ctTPC Inc.HEB2026-05-28
00860013110956Organic Light Tampons-24ctTPC Inc.HEB2026-05-28
00860013110963Organic Super Tampons-24ctTPC Inc.HEB2026-05-28
00860014539909Organic Multi Super and Super Plus Tampons-16ctTPC Inc.HEB2026-05-28
00860014539916Organic Multi Light Regular and Super Tampons-16ctTPC Inc.HEB2026-05-28
00860014539961Organic Light Tampons-36ctTPC Inc.HEB2026-05-28
00860014539978Organic Regular Tampons-36ctTPC Inc.HEB2026-05-28
00860014539985Organic Super Tampons-36ctTPC Inc.HEB2026-05-28
00860014539992Organic Multi Regular and Super Tampons-36ctTPC Inc.HEB2026-05-28
00860015263407Organic Multi Super and Super Plus Tampons-36ctTPC Inc.HEB2026-05-28
00860015263414Organic Multi Light Regular and Super Tampons-36ctTPC Inc.HEB2026-05-28
00860015263445Organic Super Plus Tampons-36ctTPC Inc.HEB2026-05-28
00860012610389Organic Regular Tampons-24ctTPC Inc.HEB2026-05-14
00860012610372Organic Multi Regular and Super Tampons-24ctTPC Inc.HEB2026-05-13
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