Lorals

GUDID 00860008392138

Brazen Goods Inc.

Oral/vaginal sex barrier, Hevea-latex

• Primary Device ID: 00860008392138
• NIH Device Record Key: 43b1c296-875b-425e-bce0-24ec76d409b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lorals
• Version Model Number: Bikini
• Company DUNS: 128095084
• Company Name: Brazen Goods Inc.
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008392138 [Unit of Use]
GS1	00860008392145 [Primary]

FDA Product Code

• MSC: Barrier, Std, Oral Sex

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-22
• Device Publish Date: 2022-08-12

On-Brand Devices [Lorals]

• 00860008392114: Shortie
• 00860008392107: Bikini
• 00860008392121: Shortie
• 00860008392138: Bikini
• 00860008392190: Shortie
• 00860008392183: Bikini