Lorals

Basic Information

• Brand Name: Lorals
• Primary DI: 00850049875004
• Version / Model: Bikini
• Company Name: Brazen Goods Inc.
• Labeler DUNS: 128095084
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2023-02-04
• Public Version: 1
• Public Version Date: 2023-02-13
• Public Version Status: New
• Public Device Record Key: bee5c807-2b3c-4691-b8c7-19a324f02d57

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
MSC	Barrier, Std, Oral Sex	Obstetrics/Gynecology	884.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47729	Oral/vaginal sex barrier, Hevea-latex	A device in the form of a flat sheet (a rubber dam), composed of Hevea-latex, designed to help reduce the risk of catching/spreading sexually transmitted infections (STI), also known as sexually transmitted diseases (STD), such as syphilis, gonorrhoea, Chlamydia infections, genital herpes, and acquired immune deficiency syndrome (AIDS ) during oral-vaginal sexual activity. It is placed over the entire vulva, covering both the vaginal opening and the clitoris, or alternatively, over the entire anal area, including the anus. It is held in place by one of the sexual partners and may be moistened with a commercially available lubricant to enhance performance. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00860008392183	GS1
Primary	00850049875004	GS1