LifeStyles Tuxedo 40 ct Bowl

GUDID 00813356000231

PARADISE MARKETING SERVICES, A CALIFORNIA CORPORATION

Basic male condom, Hevea-latex
Primary Device ID00813356000231
NIH Device Record Key0fe76270-b793-4e1a-a8da-5e38fd0b93b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameLifeStyles Tuxedo 40 ct Bowl
Version Model Number813356000231
Company DUNS038573838
Company NamePARADISE MARKETING SERVICES, A CALIFORNIA CORPORATION
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
GS100813356000231 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HISCondom

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-21
Device Publish Date2018-12-21

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