SMART SENSE Tampons

GUDID 10883967418357

KMART HOLDING CORPORATION

Menstrual tampon, unscented
Primary Device ID10883967418357
NIH Device Record Key8960acf6-f504-4ea5-9328-6e1fc53ca8c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSMART SENSE Tampons
Version Model NumberBKMUR18
Company DUNS131978533
Company NameKMART HOLDING CORPORATION
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
GS100883967418350 [Primary]
GS107290016625189 [Unit of Use]
GS110883967418357 [Package]
Contains: 00883967418350
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 Date2017-05-02

On-Brand Devices [SMART SENSE Tampons]

10883967418388Multipack Box of 36 Tampons - 18 Regular absorbency and 18 Super Absorbency
10883967418364BKMSGP36
10883967418357BKMUR18
10883967418340BKMGR36
10883967382269BKMGS18
10883967382252BKMSGS18
10883967382245BKMSGR18
10883967382238BKMGR18

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