FDA.reportPublic FDA data

INTCO

Primary DI
B845TPVPEBS21
Brand
INTCO
Company
Intco Medical Industries, Inc.
Model
TPVPEB-S2
Device description
Menstrual Unscented Tampon
Published
2023-07-20
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
K190218000
K192557000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190218000Unscented Menstrual TamponQingdao Youjia Hygiene Technology Co., Ltd.2019-05-09HEB
K192557000Youjia Unscented Tampon with Plastic ApplicatorsQingdao Youjia Hygiene Technology Co., Ltd.2020-02-13HEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B845TPVPEBS23PackageHIBCC24In Commercial Distribution
B845TPVPEBS21PrimaryHIBCC0
B845TPVPEBS2Unit of UseHIBCC0

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
080162537
Device count
18
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B845FM301A501BASICFM301A502024-06-14
B845X1021WOTUREX1022025-08-20
B845X1023WOTUREX1022025-08-20
B845X3011WOTUREX3012025-06-13
B845X3021WOTUREX3022025-06-13
B845X3013WOTUREX3012025-06-13
B845X3023WOTUREX3022025-06-13
B845FM301A50K1BASICFM301A50K2025-04-30
B845FM301A50W1BASICFM301A50W2025-04-30
B845FM301A50K3BASICFM301A50K2025-04-30
B845FM301A50W3BASICFM301A50W2025-04-30
B845CBZ0411WOTURECBZ0412025-03-28
B845CBZ0413WOTURECBZ0412025-03-28
B845CBZ041WOTURECBZ042025-03-20
B845NGPF201C31BASICNGPF201C3NGPF201C32024-09-28
B845NGPF201C41BASICNGPF201C4NGPF201C42024-09-28
B845NGPF201C51BASICNGPF201C5NGPF201C52024-09-28
B845NGPF201C61BASICNGPF201C6NGPF201C62024-09-28
B845NGPF201C71BASICNGPF201C7NGPF201C72024-09-28
B845NGPF201C81BASICNGPF201C8NGPF201C82024-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00073010720091TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010720831TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721173TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721210This is LPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721227TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721272TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721333This is LPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721340TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721517This is LPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721524This is LPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721616This is LPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721623This is LPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721685TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721807TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721845TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721906TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721968TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
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