UNIDUS LONG LOVE Shipping Carton

GUDID 18802550012330

BioGenetics CO.,LTD.

Basic male condom, Hevea-latex
Primary Device ID18802550012330
NIH Device Record Key9f967e37-6c93-43bf-8d55-0ba849882adc
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNIDUS LONG LOVE Shipping Carton
Version Model NumberPlain
Company DUNS687838789
Company NameBioGenetics CO.,LTD.
Device Count4320
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 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
GS108802550012012 [Unit of Use]
GS118802550012330 [Primary]

FDA Product Code

HISCondom

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-09-20
Device Publish Date2017-01-20

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