pjur MED Repair glide

GUDID 40827160111142

Water-based Personal Lubricant

Pjur Group Luxembourg SA

Sexual lubricant
Primary Device ID40827160111142
NIH Device Record Key84d2e33a-6305-4501-a30b-81248daa9649
Commercial Distribution StatusIn Commercial Distribution
Brand Namepjur MED Repair glide
Version Model Numberpjur MED Repair glide 2 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
GS100827160111144 [Primary]
GS110827160111141 [Package]
Contains: 00827160111144
Package: pack [50 Units]
In Commercial Distribution
GS140827160111142 [Package]
Contains: 10827160111141
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 MED Repair glide]

40827160111142Water-based Personal Lubricant
40827160106308Water-based Personal Lubricant with Hyaluron

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