Restore Moisturizing Vaginal Gel

Basic Information

• Brand Name: Restore Moisturizing Vaginal Gel
• Primary DI: 00893268000130
• Version / Model: 1.0 oz
• Catalog Number: 900250
• Company Name: GOOD CLEAN LOVE, INC.
• Labeler DUNS: 153909531
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-24
• Public Version: 3
• Public Version Date: 2021-06-22
• Public Version Status: Update
• Public Device Record Key: 48241b48-b758-4d6d-81f5-1ba0b52725af

Device Description

Restore is a patient lubricant intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.

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
KMJ	Lubricant, Patient	General Hospital	880.6375	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33587	General-body orifice lubricant, non-sterile	A non-sterile substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00893268000130	GS1
Package	30893268000131	GS1	Master Case	24	Not in Commercial Distribution	2020-12-18

Customer Contacts

• Phone: [phone]
• Email: [email protected]