Arcwave by pjur

GUDID 10827160114739

Water-based Personal Lubricant

Pjur Group Luxembourg SA

Sexual lubricant Sexual lubricant Sexual lubricant Sexual lubricant
Primary Device ID10827160114739
NIH Device Record Key352ad446-7591-43c6-8eb8-03ea3c8cba91
Commercial Distribution StatusIn Commercial Distribution
Brand NameArcwave by pjur
Version Model NumberArcwave by pjur - 100ml - 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
GS100827160114732 [Primary]
GS100827160114732 [Primary]
GS100827160114732 [Primary]
GS100827160114732 [Primary]
GS110827160114739 [Package]
Contains: 00827160114732
Package: pack [6 Units]
In Commercial Distribution
GS110827160114739 [Package]
Contains: 00827160114732
Package: pack [6 Units]
In Commercial Distribution
GS110827160114739 [Package]
Contains: 00827160114732
Package: pack [6 Units]
In Commercial Distribution
GS110827160114739 [Package]
Contains: 00827160114732
Package: pack [6 Units]
In Commercial Distribution
GS140827160114730 [Package]
Package: case [16 Units]
In Commercial Distribution
GS140827160114730 [Package]
Package: case [16 Units]
In Commercial Distribution
GS140827160114730 [Package]
Package: case [16 Units]
In Commercial Distribution
GS140827160114730 [Package]
Package: case [16 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NUCLubricant, Personal
NUCLubricant, Personal
NUCLubricant, Personal
NUCLubricant, Personal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-10
Device Publish Date2020-11-02

On-Brand Devices [Arcwave by pjur]

40827160114211Water-based Personal Lubricant
10827160114739Water-based Personal Lubricant

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