Exchange Select Tampons

GUDID 10614299407166

Aafes

Menstrual tampon, unscented
Primary Device ID10614299407166
NIH Device Record Key003f5fb3-eabd-40ea-8747-5be0b5ecac91
Commercial Distribution StatusIn Commercial Distribution
Brand NameExchange Select Tampons
Version Model NumberBAFUR18
Company DUNS001695568
Company NameAafes
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
GS100614299407169 [Primary]
GS107290016625189 [Unit of Use]
GS110614299407166 [Package]
Contains: 00614299407169
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 Date2016-09-20

On-Brand Devices [Exchange Select Tampons]

10614299407203BAFUS18
10614299407166BAFUR18
10614299402062BAFGS18
10614299402055BAFGR20
10614299396408Multi pack of 40 tampons - 8 Light, 16 Regular and 16 Super absorbency
10614299396385BAFAR20
10614299396378BAFAS20

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