FDA UDI
In Commercial Distribution
🇺🇸 United States
HYALO GYN Vaginal Hydrating Gel, 30g Tube
DI: M71389122179604A15
·
Model: 179604
·
FIDIA FARMACEUTICI SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HYALO GYN Vaginal Hydrating Gel, 30g Tube
- Primary DI
- M71389122179604A15
- Version / Model
- 179604
- Catalog Number
- 179604
- Company Name
- FIDIA FARMACEUTICI SPA
- Labeler DUNS
- 428453013
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-01
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- c564896c-6502-4bb9-a467-1afdbc975f1a
Device Description
HYALO GYN® is a personal lubricant, for penile and/or 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 condoms: lubricated/nonlubricated latex, lubricated polyurethane, lubricated natural skin.
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 |
|---|---|---|---|---|
| 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 | M71389122179604A15 | HIBCC |
Customer Contacts
- Phone
- 973-552-2567
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K094039 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 33 – 103 Degrees Fahrenheit