pjur Backdoor water-based

GUDID 40827160112163

Water-based Personal Lubricant with Hyaluron

Pjur Group Luxembourg SA

Sexual lubricant
Primary Device ID40827160112163
NIH Device Record Keye65f2c3b-de9e-4e92-9354-cd46842c7d6f
Commercial Distribution StatusIn Commercial Distribution
Brand Namepjur Backdoor water-based
Version Model Numberpjur backdoor waterbased 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
GS100827160112165 [Primary]
GS110827160112162 [Package]
Contains: 00827160112165
Package: pack [12 Units]
In Commercial Distribution
GS140827160112163 [Package]
Contains: 10827160112162
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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-09
Device Publish Date2017-01-25

On-Brand Devices [pjur Backdoor water-based]

40827160112279Water-based Personal Lubricant with Hyaluron
40827160112163Water-based Personal Lubricant with Hyaluron

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