DynaCare Tampons, Regular, Plastic Applicator

GUDID 08401173284198

DYNAREX CORPORATION

Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented
Primary Device ID08401173284198
NIH Device Record Keybd69968e-58d6-4b8b-9372-8ca49cb4c99d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynaCare Tampons, Regular, Plastic Applicator
Version Model Number1357R-BULK
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count500
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840117328419 [Primary]
GS108401173284198 [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 Date2024-03-14
Device Publish Date2024-03-06

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