DynaCare Tampons Super,Cardboard Applicator

Primary DI
00840117328426
Brand
DynaCare Tampons Super,Cardboard Applicator
Company
Dynarex Corporation
Model
1355S
Device description
Unscented, Free of Dyes & Perfumes
Published
2024-05-09
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
K191666000
K241064000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191666000Unscented W long plastic and cardboard applicator tamponsOntex Bvba2019-12-20HEB
K241064000Unscented TamponShandong Intco Hygiene Products Co., Ltd.2025-01-10HEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117328754PackageGS19In Commercial Distribution
00840117328426PrimaryGS10
00810180840125Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117328754008401173287548401173287540840117328754
00840117328426008401173284268401173284260840117328426
00810180840125008101808401258101808401250810180840125

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
25
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

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