Regular Tampons Plastic Applicator

GUDID 00840117328440

Not Sterile

DYNAREX CORPORATION

Menstrual tampon, unscented
Primary Device ID00840117328440
NIH Device Record Key3e3ff418-a2f0-4c91-8a65-510666a31535
Commercial Distribution StatusIn Commercial Distribution
Brand NameRegular Tampons Plastic Applicator
Version Model Number1357R
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count25
DM Exemptfalse
Pre-market Exempttrue
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
GS100840117328440 [Package]
Contains: 00840117328778
Package: Case [9 Units]
In Commercial Distribution
GS100840117328761 [Unit of Use]
GS100840117328778 [Primary]
GS108401173287786 [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 Date2023-12-29
Device Publish Date2023-12-21

Devices Manufactured by DYNAREX CORPORATION

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00840117312920 - Resp-O2 Endotracheal Tube Cuffed, 4.5 mm 2024-11-01 Sterile-EO
00840117317475 - Resp-O2 Endotracheal Tube Cuffed, 5.0 mm 2024-11-01 Sterile-EO
00840117312968 - Resp-O2 Endotracheal Tube Cuffed, 5.5 mm 2024-11-01 Sterile-Eo
00840117312982 - Resp-O2 Endotracheal Tube Cuffed, 6.0 mm 2024-11-01 Sterile-Eo
00840117313002 - Resp-O2 Endotracheal Tube Cuffed, 6.5 mm2024-11-01 Sterile-Eo

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