pjur MED Sensitive glide

GUDID 40827160112606

Water-based Personal Lubricant

Pjur Group Luxembourg SA

Sexual lubricant
Primary Device ID40827160112606
NIH Device Record Key101e7471-0ecc-4ba8-ab3c-a2c59eccedae
Commercial Distribution StatusIn Commercial Distribution
Brand Namepjur MED Sensitive glide
Version Model Numberpjur MED Sensitive glide 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
GS100827160112608 [Primary]
GS110827160112605 [Package]
Contains: 00827160112608
Package: pack [12 Units]
In Commercial Distribution
GS140827160112606 [Package]
Contains: 10827160112605
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 Date2017-07-14

Devices Manufactured by Pjur Group Luxembourg SA

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10827160116290 - pjur AQUA Natural2024-05-08 Water-based Personal Lubricant
10827160115255 - pjur INFINITY silicone-based 2022-11-14 Silicone-based Personal Lubricant
10827160115262 - pjur INFINITY water-based 2022-11-14 water-based Personal Lubricant
10827160115163 - pjur INFINITY silicone-based 2022-10-03 Silicone-based Personal Lubricant
10827160115170 - pjur INFINITY water-based 2022-10-03 water-based Personal Lubricant

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