FDA UDI
In Commercial Distribution
🇺🇸 United States
Eroxon
DI: 00307663076091
·
Model: Eight Pack
·
Haleon US Holdings LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
8
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Basic Information
- Brand Name
- Eroxon
- Primary DI
- 00307663076091
- Version / Model
- Eight Pack
- Company Name
- Haleon US Holdings LLC
- Labeler DUNS
- 079944263
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 8
- Record Status
- Published
- Publish Date
- 2025-04-01
- Public Version
- 1
- Public Version Date
- 2025-04-09
- Public Version Status
- New
- Public Device Record Key
- a9789bcb-dcd8-4462-acee-fd2415349d41
Device Description
Eight single-use tubes of Eroxon gel in one carton.
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| QWW | Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction. | Gastroenterology, Urology | 876.5021 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66929 | Penile cooling/warming gel | A gel/jelly-like substance intended to be applied to the head of the penis for the management of erectile dysfunction (ED) (commonly known as impotence) by enabling the maintenance of a penile erection adequate for sexual intercourse. The gel stimulates erection by providing a cooling effect as the volatile components (e.g., alcohol, water) evaporate, followed by a warming effect due to the body’s efferent response (thermoregulation), resulting in increased blood flow to the penis. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00307663075896 | GS1 | ||||
| Primary | 00307663076091 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN220078 | 000 |