pjur INFINITY silicone-based 13967-02

GUDID 10827160115163

Silicone-based Personal Lubricant

Pjur Group Luxembourg SA

Sexual lubricant
Primary Device ID10827160115163
NIH Device Record Key87da70db-879e-4246-b4b3-cf52fa66046f
Commercial Distribution StatusIn Commercial Distribution
Brand Namepjur INFINITY silicone-based
Version Model Numberpjur INFINITY silicone-based, 50ml
Catalog Number13967-02
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
GS100827160115166 [Primary]
GS110827160115163 [Package]
Contains: 00827160115166
Package: pack [6 Units]
In Commercial Distribution
GS140827160115164 [Package]
Package: case [48 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 Date2022-10-03
Device Publish Date2022-09-23

On-Brand Devices [pjur INFINITY silicone-based ]

10827160115163Silicone-based Personal Lubricant
10827160115255Silicone-based Personal Lubricant

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