pjur med HYDRO glide

GUDID 10827160114999

Water-based Personal Lubricant

Pjur Group Luxembourg SA

Sexual lubricant
Primary Device ID10827160114999
NIH Device Record Keybf245eb8-e8b3-4cc9-be53-7810b72b20a8
Commercial Distribution StatusIn Commercial Distribution
Brand Namepjur med HYDRO glide
Version Model Numberpjur med HYDRO 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
GS100827160114992 [Primary]
GS110827160114999 [Package]
Contains: 00827160114992
Package: pack [12 Units]
In Commercial Distribution
GS140827160114990 [Package]
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 Date2021-10-18
Device Publish Date2021-10-08

Devices Manufactured by Pjur Group Luxembourg SA

00827160114367 - pjur WOMAN Nude2024-05-31 Water-based Personal Lubricant Mini-Collection USA
10827160116276 - pjur med HYDRO2024-05-08 Water-based Personal Lubricant
10827160116283 - pjur med SENSITIVE2024-05-08 Water-based Personal Lubricant
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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