Identity
- Trade Name
- HYALO GYN Vaginal Hydrating Gel, 30g Tube FDA UDI
- Generic Name
- Vaginal lubricant FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 179604 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 179604 FDA UDI
- Primary DI / UDI-DI
- M71389122179604A15 FDA UDI
- 510(k) Number
- K094039 FDA UDI
- FDA Product Code
- NUC FDA UDI
- GMDN Term
- Vaginal lubricant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vaginal lubricant
HYALO GYN Vaginal Hydrating Gel, 30g Tube by Fidia Farmaceutici — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K094039 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fidia Farmaceutici
Sources (1)
- FDA UDI c564896c-6502-4bb9-a467-1afdbc975f1a 37 fields · synced May 31, 2026