Core Values Tampons

GUDID 10834533000971

HARMON STORES, INC.

Menstrual tampon, unscented
Primary Device ID10834533000971
NIH Device Record Keyc4b9b246-f587-4009-a0e7-580028a30b12
Commercial Distribution StatusIn Commercial Distribution
Brand NameCore Values Tampons
Version Model NumberBHAXS18
Company DUNS804085293
Company NameHARMON STORES, 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

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Device Identifiers

Device Issuing AgencyDevice ID
GS100834533000974 [Primary]
GS107290016625288 [Unit of Use]
GS110834533000971 [Package]
Contains: 00834533000974
Package: CASE [12 Units]
In Commercial Distribution

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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-07-31

On-Brand Devices [Core Values Tampons]

10075289521123BHAGR20
10075289521116BHAAR20
10834533001114BHAGS05
10834533001107BHAGR05
10834533000957BHAGS18
10834533000940Multi pack of 36 tampons - 8 Light, 20 Regular and 8 Super absorbency
10834533000971BHAXS18
10834533000964BHAXR18

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