Identity
- Trade Name
- LubriGel FDA UDI
- Generic Name
- Vaginal lubricant FDA UDI
- Device Name
- Sheffield LubriGel is a FDA clear class 2 device sold as a personal lubricant filled into a 3.0 OZ tube packed into a carton FDA UDI
- Model / Reference
- 5442103 FDA UDI
- Description
- Sheffield LubriGel is a FDA clear class 2 device sold as a personal lubricant filled into a 3.0 OZ tube packed into a carton FDA UDI
Identifiers
- Catalog Number
- 08103024 FDA UDI
- Primary DI / UDI-DI
- 00732953081033 FDA UDI
- 510(k) Number
- K001077 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
LubriGel by Sheffield Pharmaceuticals LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K001077 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
- Sheffield Pharmaceuticals LLC
Sources (1)
- FDA UDI a360c4db-e80d-4c54-ab07-1d072cea47a8 37 fields · synced May 30, 2026