FDA.reportPublic FDA data

Quality choice Tampons

Primary DI
10635515995489
Brand
Quality choice Tampons
Company
CHAIN DRUG MARKETING ASSOCIATION, INC.
Model
BQCUS18
Published
2016-09-20
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090071000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090071000ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONSRostam , Ltd.2009-05-28HEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10635515995489PackageGS112In Commercial Distribution
00635515995482PrimaryGS10
07290016625196Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063551599548910635515995489
00635515995482006355159954826355159954820635515995482
07290016625196072900166251967290016625196

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
011920774
Device count
18
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
00635515998537Quality Choice6355159985372021-08-09
00635515947443QUALITY CHOICE89-352QC-947442017-02-15
00635515958920QUALITY CHOICE89-362QC-958922017-02-15
00635515986701QUALITY CHOICE89-375QC-986702017-02-15
00635515992207QUALITY CHOICE89-355QC-992202017-02-15
00635515986794QUALITY CHOICE89-50KQC-986792017-02-15
00635515900486Quality Choice One Step Pregnancy TestFPPL2016-07-21
00635515956643Quality Choice Early Result Pregnancy TestPLPL2016-07-21
00635515900493Quality Choice One Step Pregnancy TestFPPL2016-07-21
00635515970717Quality Choice Early Result Pregnancy TestPLPL2016-07-21
00635515959347Quality Choice AutoletAT 0274QC2023-02-03
00761059276333Quality Choice AutoletAT 0274QC2023-02-03
00635515959354Quality Choice UniletAT 0575QC2023-01-26
00635515959361Quality Choice UniletAT 0565QC2023-01-26
00635515994775Quality Choice UniletAT 0585QC2023-01-26
00635515966130Quality ChoiceQC-96613QC-966132022-06-16
10635515966137Quality ChoiceQC-96613QC-966132022-06-16
00635515958838Quality choice TamponsBQCGR202016-09-20
00635515958845Quality choice TamponsBQCGS182016-09-20
00635515958852Quality choice TamponsBQCGP182016-09-20

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