FDA.reportPublic FDA data

DynaCare Tampons,Super,Plastic Applicator

Primary DI
08401173287854
Brand
DynaCare Tampons,Super,Plastic Applicator
Company
DYNAREX CORPORATION
Model
1357S
Device description
Unscented, Free of Dyes & Perfumes
Published
2024-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
K222046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222046000Unscented Menstrual TamponSuzhou Borage Medical Technology Co., Ltd.2022-09-30HEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117328464PackageGS19In Commercial Distribution
00840117328785PrimaryGS10
08401173287854Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117328464008401173284648401173284640840117328464
00840117328785008401173287858401173287850840117328785
08401173287854084011732878548401173287854

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
008124539
Device count
25
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117311411Resp-O2 Nasal O2 Cannula Cushion Tip331542021-04-22
00840117311435Resp-O2 Nasal O2 Cannula Cushion Tip331552021-04-22
00840117311459Resp-O2 Nasal O2 Cannula Cushion Tip331562021-04-22
00840117311473Resp-O2 Nasal O2 High Flow Cannula331602021-04-22
00840117311718Resp-O2 Nasal Oxygen Cannula Deluxe Ear Foam Covers333002021-04-22
00840117316416Resp-O2 Nasal O2 Cannula Cushion Tip331702021-04-22
00840117316423Resp-O2 Nasal O2 Cannula Cushion Tip331712021-04-22
00840117316430Resp-O2 Nasal O2 Cannula Cushion Tip331722021-04-22
00840117316447Resp-O2 Nasal O2 Cannula Cushion Tip331732021-04-22
00840117316454Resp-O2 Nasal O2 Cannula Cushion Tip331742021-04-22
00840117316461Nasal O2 Cannula Cushion Tip331752021-04-22
00840117316478Resp-O2 Nasal O2 Cannula Cushion Tip331762021-04-22
00840117316577Resp-O2 EtCO2 Nasal Sampling Cannula331802021-04-22
00840117316584Resp-O2 EtCO2 Nasal Sampling Cannula331812021-04-22
00840117316591Resp-O2 EtCO2 Nasal Sampling Cannula331822021-04-22
00840117316607Resp-O2 EtCO2 Nasal Sampling Cannula331832021-04-22
00840117316614Resp-O2 EtCO2 Nasal Sampling Cannula331842021-04-22
00840117316621Resp-O2 EtCO2 Nasal Sampling Cannula331852021-04-22
00840117316638Resp-O2 EtCO2 Nasal Sampling Cannula331862021-04-22
00840117316645Resp-O2 EtCO2 Nasal Sampling Cannulas331872021-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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00196852637379Organic Super Tampons-16ct Original PackagingTPC Inc.HEB2026-05-28
00196852929245Organic Regular Tampons-16ct Original PackagingTPC Inc.HEB2026-05-28
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00860012610303Organic Regular and Super Tampons-16ctTPC Inc.HEB2026-05-28
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00860013110925Organic Super Tampons-16ctTPC Inc.HEB2026-05-28
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00860013110956Organic Light Tampons-24ctTPC Inc.HEB2026-05-28
00860013110963Organic Super Tampons-24ctTPC Inc.HEB2026-05-28