pjur MAN Extreme

GUDID 40827160112095

Silicone-based Personal Lubricant

Pjur Group Luxembourg SA

Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant
Primary Device ID40827160112095
NIH Device Record Keycf245d5d-8843-4b32-94ed-e05fcac5d613
Commercial Distribution StatusIn Commercial Distribution
Brand Namepjur MAN Extreme
Version Model Numberpjur MAN Extreme 100 ml - USA
Company DUNS400744553
Company NamePjur Group Luxembourg SA
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 Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100827160112097 [Primary]
GS110827160112094 [Package]
Contains: 00827160112097
Package: pack [12 Units]
In Commercial Distribution
GS140827160112095 [Package]
Contains: 10827160112094
Package: case [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NUCLubricant, Personal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-04
Device Publish Date2018-12-04

On-Brand Devices [pjur MAN Extreme]

40827160112217Silicone-based Personal Lubricant
40827160112095Silicone-based Personal Lubricant

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