DynaCare Tampons, Super Plus, Plastic Applicator

GUDID 00840117328471

Unscented, Free Of Dyes & Perfumes

DYNAREX CORPORATION

Menstrual tampon, unscented
Primary Device ID00840117328471
NIH Device Record Key5f8bd746-eb96-44aa-87ce-a6c720ec4173
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynaCare Tampons, Super Plus, Plastic Applicator
Version Model Number1357SP
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count20
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810180841917 [Unit of Use]
GS100840117328471 [Package]
Contains: 00840117328792
Package: Case [10 Units]
In Commercial Distribution
GS100840117328792 [Primary]
GS108401173287922 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HEBTampon, Menstrual, Unscented

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-15
Device Publish Date2024-03-07

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