FDA.reportPublic FDA data

Iris + Arlo

Primary DI
00628719704639
Brand
Iris + Arlo
Company
Iris + Arlo Inc.
Model
1
Published
2026-01-06
Public version status
New
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
K091084000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091084000MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONSCotton High Tech S.L.2009-04-29HEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628719704639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628719704639006287197046396287197046390628719704639

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
144884489
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628719704004Iris + Arlo12026-01-06
00628719704011Iris + Arlo12026-01-06
00628719704035Iris + Arlo12026-01-06
00628719704042Iris + Arlo12026-01-06
00628719704059Iris + Arlo12026-01-06
00628719704073Iris + Arlo12026-01-06
00628719704127Iris + Arlo12026-01-06
00628719704134Iris + Arlo12026-01-06
00628719704554Iris + Arlo12026-01-06
00628719704561Iris + Arlo12026-01-06
00628719704578Iris + Arlo12026-01-06
00628719704592Iris + Arlo12026-01-06
00628719704608Iris + Arlo12026-01-06
00628719704615Iris + Arlo12026-01-06
00628719704646Iris + Arlo12026-01-06
00628719704660Iris + Arlo12026-01-06
00628719704677Iris + Arlo12026-01-06
00628719704684Iris + Arlo12026-01-06
00628942539305Iris + Arlo12026-01-06
00628942539312Iris + Arlo12026-01-06

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