Arcwave by pjur

Basic Information

• Brand Name: Arcwave by pjur
• Primary DI: 00827160114213
• Version / Model: Arcwave by pjur 10ml
• Company Name: Pjur Group Luxembourg SA
• Labeler DUNS: 400744553
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-08
• Public Version: 2
• Public Version Date: 2020-08-07
• Public Version Status: Update
• Public Device Record Key: 37b0fb29-5293-4536-8b3c-bff6efe1ac92

Device Description

Water-based Personal Lubricant

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NUC	Lubricant, Personal	Obstetrics/Gynecology	884.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60412	Sexual lubricant	A substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40827160114211	GS1	case	500	In Commercial Distribution
Package	10827160114210	GS1	pack	50	In Commercial Distribution
Primary	00827160114213	GS1

Premarket Submissions

Submission Number	Supplement Number
K010199	000