pjur Woman

GUDID 40827160100092

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 ID40827160100092
NIH Device Record Keyc2145497-efc0-4281-a259-0ad3d5c8a912
Commercial Distribution StatusIn Commercial Distribution
Brand Namepjur Woman
Version Model Numberpjur Woman 1,5 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
GS100827160100094 [Primary]
GS110827160100091 [Package]
Contains: 00827160100094
Package: pack [50 Units]
In Commercial Distribution
GS140827160100092 [Package]
Contains: 10827160100091
Package: case [20 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 Woman]

40827160107282Silicone-based Personal Lubricant
40827160101860Silicone-based Personal Lubricant
40827160101853Silicone-based Personal Lubricant
40827160100092Silicone-based Personal Lubricant

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