FRED'S TAMPONS

GUDID 10084579122476

REGULAR SCENTED PLASTIC APPLICATOR TAMPONS

FRED'S, INC.

Menstrual tampon, scented
Primary Device ID10084579122476
NIH Device Record Key670b0c3d-5ff7-4fed-abf8-345a3a6f550c
Commercial Distribution StatusIn Commercial Distribution
Brand NameFRED'S TAMPONS
Version Model NumberFR11806SO
Company DUNS005866116
Company NameFRED'S, INC.
Device Count18
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
GS100008457912242 [Unit of Use]
GS100084579122479 [Primary]
GS110084579122476 [Package]
Contains: 00084579122479
Package: CASE [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HILTampon, Menstrual, Scented, Deodorized

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-01
Device Publish Date2016-09-13