FDA UDI
In Commercial Distribution
🇺🇸 United States
HYALO GYN Vaginal Hydrating Gel, 10g Tube - Made without Parabens Sample
DI: M7133797040
·
Model: 379704
·
FIDIA FARMACEUTICI SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HYALO GYN Vaginal Hydrating Gel, 10g Tube - Made without Parabens Sample
- Primary DI
- M7133797040
- Version / Model
- 379704
- Catalog Number
- 379704
- Company Name
- FIDIA FARMACEUTICI SPA
- Labeler DUNS
- 428453013
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-25
- Public Version
- 1
- Public Version Date
- 2021-04-02
- Public Version Status
- New
- Public Device Record Key
- 76961b24-c13c-4b8e-af17-4051a9131f19
Device Description
HYALO GYN® Made without parabens is a personal lubricant for vaginal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is compatible with polyisoprene condoms.
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| NUC | Lubricant, Personal | Obstetrics/Gynecology | 884.5300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34131 | Vaginal lubricant | A non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M7133797040 | HIBCC |
Customer Contacts
- Phone
- 973-577-6202
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 33 – 103 Degrees Fahrenheit