ONE® Oasis Silk bottle

Basic Information

• Brand Name: ONE® Oasis Silk bottle
• Primary DI: 00726893210158
• Version / Model: 11L401
• Company Name: GLOBAL PROTECTION CORP.
• Labeler DUNS: 364614362
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-04
• Public Version: 2
• Public Version Date: 2023-08-21
• Public Version Status: Update
• Public Device Record Key: c883f9e0-315a-4eab-9b23-3b1104d9b873

Device Description

ONE® Oasis Silk 2oz Tube

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
Primary	00726893210158	GS1
Package	20726893210152	GS1	case of 96	96	In Commercial Distribution

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature in a dark, dry place. Avoid excessive heat.