FDA.reportPublic FDA data

DynaCare Tampons Regular Cardboard Applicator

Primary DI
00810180840040
Brand
DynaCare Tampons Regular Cardboard Applicator
Company
Dynarex Corporation
Model
1355R-Bulk
Device description
Not-Sterile
Published
2024-07-25
Public version status
Update
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
K191666000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191666000Unscented W long plastic and cardboard applicator tamponsOntex Bvba2019-12-20HEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117328457PrimaryGS10
00810180840040Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117328457008401173284578401173284570840117328457
00810180840040008101808400408101808400400810180840040

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
500
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
00840117322547Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363702026-10-23
00840117322554Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363712026-10-23
00840117322561Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363722026-10-23
00840117322578Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363732026-10-23
00840117322585Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363742026-10-23
00840117348684dmecare Solutions Folding Bedside Commode, With Collapsible Bucket10372C2026-10-23
00840117339057Durma+ Transparent Film Dressing, Frame Style, Sterile36472024-12-13
00840117339088Durma+ Transparent Film Dressing, Frame Style36482024-12-13
00616784319438Compress Bandages, Offset, Sterile31942021-06-21
00840117307360Child Face Masks2207-CHCR2021-06-21
00616784245119SafeTouch Sterile Latex Examination Gloves, Powder-Free, Cuffed, Ambidextrous24512026-10-01
00616784245218SafeTouch Sterile Latex Examination Gloves, Powder-Free, Cuffed, Ambidextrous24522026-10-01
00616784316925Cotton Balls, Large31692026-10-01
00616784317021Cotton Balls, Medium31702026-10-01
00616784671628SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrou67162026-09-30
00616784671727SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67172026-09-30
00616784671826SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67182026-09-30
00616784671925SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67192026-09-30
00840117346147Resp-O2 M24 Oxygen E-Cylinder, With CGA 870 Toggle Valve, 4.55 L36390-TBULK2026-09-28
00840117346154Resp-O2 M15 Oxygen Standard D-Cylinder, With CGA 870 Toggle Valve36391-TBULK2026-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972465050002Borage MedicalSuzhou Borage Medical Technology Co.,Ltd.HEB2026-10-10
06972465050309Borage MedicalSuzhou Borage Medical Technology Co.,Ltd.HEB2026-10-10
06972465050323Borage MedicalSuzhou Borage Medical Technology Co.,Ltd.HEB2026-10-09
06972465050361Borage MedicalSuzhou Borage Medical Technology Co.,Ltd.HEB2026-10-09
05060994741759DayeTAMPON INNOVATIONS LTD OODHEB2026-10-07
05060994741766DayeTAMPON INNOVATIONS LTD OODHEB2026-10-07
05060994741773DayeTAMPON INNOVATIONS LTD OODHEB2026-10-07
05060994741780DayeTAMPON INNOVATIONS LTD OODHEB2026-10-07
08806011638117Dong-A Pharmaceutical Co., Ltd.Dong-A Pharmaceutical Co., Ltd.HEB2026-09-29
05060994740752DayeTAMPON INNOVATIONS LTD OODHEB2026-09-25
05060994740769DayeTAMPON INNOVATIONS LTD OODHEB2026-09-25
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00036000602609KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602616KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
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00036000602654KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000602661KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
00036000606126KotexKIMBERLY-CLARK GLOBAL SALES, INC.HEB2026-09-20
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00073010721524This is LPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25