pjur Silicone Gel

GUDID 40827160112040

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 ID40827160112040
NIH Device Record Keyaeb2450f-236a-4e30-bb38-a1efbfe721c0
Commercial Distribution StatusIn Commercial Distribution
Brand Namepjur Silicone Gel
Version Model Numberpjur Silicone Gel 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
GS100827160112042 [Primary]
GS110827160112049 [Package]
Contains: 00827160112042
Package: pack [12 Units]
In Commercial Distribution
GS140827160112040 [Package]
Contains: 10827160112049
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 Date2017-05-01

Devices Manufactured by Pjur Group Luxembourg SA

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
10827160115422 - pjur AQUA Naked2022-07-21 Water-based Personal Lubricant
10827160115439 - pjur AQUA Natural2022-07-21 Water-based Personal Lubricant
10827160115187 - pjur AQUA Aloe2022-03-30 Water-based Personal Lubricant
10827160114999 - pjur med HYDRO glide2021-10-18 Water-based Personal Lubricant

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