Shibari - Ultra Lube - 8 floz / 240 mL

Basic Information

• Brand Name: Shibari - Ultra Lube - 8 floz / 240 mL
• Primary DI: 00796494003473
• Version / Model: 70769
• Company Name: CC Wellness LLC
• Labeler DUNS: 067692292
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-12
• Public Version: 2
• Public Version Date: 2023-10-09
• Public Version Status: Update
• Public Device Record Key: 57ee9290-fb19-49fe-88bb-024e021a480c

Device Description

Water-based Personal Lubricant

Device Characteristics

• Single Use: Yes
• 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	10796494003470	GS1		72	In Commercial Distribution
Primary	00796494003473	GS1

Premarket Submissions

Submission Number	Supplement Number
K171021	000