Eroxon 99990

GUDID 00079255499990

Eroxon is a clinically proven gel treatment for adult men with erectile dysfunction, or ED, which is the inability to get or keep an erection sufficient for satisfactory sexual activity.

Lil' Drug Store Products, Inc.

Penile cooling/warming gel

• Primary Device ID: 00079255499990
• NIH Device Record Key: 40e57095-bb06-4bbb-9129-0205c4193767
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eroxon
• Version Model Number: 99990
• Catalog Number: 99990
• Company DUNS: 093103646
• Company Name: Lil' Drug Store Products, Inc.
• Device Count: 2
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00079255499990 [Unit of Use]
GS1	00792554999908 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN220078

FDA Product Code

• QWW: Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.

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: 2024-10-29
• Device Publish Date: 2024-10-21