pjur INFINITY silicone-based

GUDID 10827160115255

Silicone-based Personal Lubricant

Pjur Group Luxembourg SA

Sexual lubricant
Primary Device ID10827160115255
NIH Device Record Key98d4c54f-a55d-40c1-abb8-7790f40146c7
Commercial Distribution StatusIn Commercial Distribution
Brand Namepjur INFINITY silicone-based
Version Model Numberpjur INFINITY silicone-based, 1,5ml
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
GS100827160115258 [Primary]
GS110827160115255 [Package]
Contains: 00827160115258
Package: pack [50 Units]
In Commercial Distribution
GS140827160115256 [Package]
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 Date2022-11-14
Device Publish Date2022-11-04

On-Brand Devices [pjur INFINITY silicone-based ]

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

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