ONE

GUDID 00850002174120

ONE Vanish Latex Condom

LUNAMAX LLC

Basic male condom, Hevea-latex
Primary Device ID00850002174120
NIH Device Record Keye9128f4d-004f-4a3b-9fa2-e0cf24302b90
Commercial Distribution StatusIn Commercial Distribution
Brand NameONE
Version Model NumberGS130
Company DUNS106855461
Company NameLUNAMAX LLC
Device Count1
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850002174120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HISCondom

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-28
Device Publish Date2018-11-27

On-Brand Devices [ONE]

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00850002174762ONE Chocolate Mint Flavored Latex Condom
00850002174755ONE Banana Split Flavored Latex Condom
00850002174748ONE Fresh Mint Flavored Latex Condom
00850002174731ONE Chocolate Strawberry Flavored Latex Condom
00850002174724ONE Island Punch Flavored Latex Condom
00850002174717ONE Bubblegum Flavored Latex Condom
00850002174663ONE Super Sensitive Latex Condom
00850002174656ONE Color Sensations Latex Condom
00850002174649ONE Glowing Pleasures Latex Condom
00850002174427ONE Flavor Waves Flavored Latex Condom
00850002174410ONE Super Studs Latex Condoms
00850002174373ONE Pleasure Dome Latex Condom
00850002174366ONE Tattoo Touch Latex Condom
00850002174359ONE Legend Latex Condom
00850002174342ONE Legend Latex Condom
00850002174250ONE Vanish Latex Condom
00850002174243ONE Zero Thin Latex Condom
00850002174236ONE Zero Thin Latex Condom
00850002174120ONE Vanish Latex Condom

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