Eroxon

GUDID 00307663074806

Four single-use tubes of Eroxon gel in one carton.

Haleon US Holdings LLC

Penile cooling/warming gel

• Primary Device ID: 00307663074806
• NIH Device Record Key: 22758c0a-7a69-4987-9e45-69f4fb4dc778
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eroxon
• Version Model Number: Four Pack
• Company DUNS: 079944263
• Company Name: Haleon US Holdings LLC
• Device Count: 4
• 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	00307663074806 [Primary]
GS1	00307663075896 [Unit of Use]

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: 2024-10-04
• Device Publish Date: 2024-09-26