FDA.reportPublic FDA data

DynaCare Organic Tampons, Regular, Cardboard Applicator

Primary DI
00840117343405
Brand
DynaCare Organic Tampons, Regular, Cardboard Applicator
Company
Dynarex Corporation
Model
1378
Device description
Regular: 6-9 G, Super 3-12 G, Super Plus: 12-15 G. Ingredients: 100% Organic Cotton (Wadding), 100% Organic Cotton (Non-Woven), Organic Cotton (Withdrawal Cord), Cardboard (Applicator).Warning: Tampons are associated with Toxic Shock Syndrome (TSS). TSS is a rare but serious disease that may cause death. Read and save the enclosed information.
Published
2025-06-05
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
K090819000
K241064000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090819000ONTEX TAMPON (UNSCENTED)Ontex International NV2009-12-23HEB
K241064000Unscented TamponShandong Intco Hygiene Products Co., Ltd.2025-01-10HEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117343405PrimaryGS10
00810180842075Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117343405008401173434058401173434050840117343405
00810180842075008101808420758101808420750810180842075

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.

Regulatory Flags#

DUNS number
008124539
Device count
500
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117311534Resp-O2 Oxygen Supply Tubing332002021-04-22
00840117311558Resp-O2 Oxygen Supply Tubing332012021-04-22
00840117311572Resp-O2 Oxygen Supply Tubing332022021-04-22
00840117311596Resp-O2 Oxygen Supply Tubing332032021-04-22
00840117311619Resp-O2 Oxygen Supply Tubing332042021-04-22
00840117311633Resp-O2 Oxygen Supply Tubing332052021-04-22
00840117311657Resp-O2 Oxygen Supply Tubing332062021-04-22
00840117311671Resp-O2 Oxygen Supply Tubing332072021-04-22
00840117311695Resp-O2 Oxygen Supply Tubing332082021-04-22
00840117318625Resp-O2 Oxygen Tubing Inline Water Traps333022021-04-22
00840117318632Resp-O2 Oxygen Tubing 22mm I.D. x 5-7 mm Tapered Nipple Adaptors333032021-04-22
00840117318649Resp-O2 Oxygen Tubing 5-7 mm End Adaptors333042021-04-22
00840117318663Resp-O2 Oxygen Tubing Y Adaptors333062021-04-22
00840117318670Resp-O2 Oxygen Tubing Nut Nipple Adaptors333072021-04-22
00840117318687Resp-O2 Oxygen Tubing Nut Nipple Swivel Adaptors333082021-04-22
00840117318694Resp-O2 Portable Oxygen Liter Meters333092021-04-22
00840117342361Resp-O2 EtCO2 Nasal Sampling Cannula, 10' (3.0m) O2 and CO2 Tubing331982025-06-09
00840117342408Resp-O2 EtCO2 Nasal Sampling Cannula, 14' (4.2 m) O2 and CO233199-F2025-06-09
00840117324008Resp-O2 Compressor, 50 PSI339522022-07-11
00840117310254Resp-O2 Oxygen Concentrator, 5L339502022-05-10

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Primary DI, Brand, Company table
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00073010721340TampaxPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
00073010721517This is LPROCTER & GAMBLE MANUFACTURING COMPANY, THEHEB2026-06-25
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