Identity
- Trade Name
- Sasmar Classic FDA UDI
- Generic Name
- General-body orifice lubricant, non-sterile FDA UDI
- Device Name
- PERSONAL LUBRICANT FDA UDI
- Model / Reference
- 60ml FDA UDI
- Description
- PERSONAL LUBRICANT FDA UDI
Identifiers
- Catalog Number
- 880821 FDA UDI
- Primary DI / UDI-DI
- 09337213008211 FDA UDI
- 510(k) Number
- K131084 FDA UDI
- FDA Product Code
- NUC FDA UDI
- GMDN Term
- General-body orifice lubricant, non-sterile 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
No
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 lubricantGeneral-body orifice lubricant, non-sterile
Sasmar Classic by Sasmar Pharmaceuticals SPRL — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K131084 also covers:
- Sasmar Cherry — Sasmar Pharmaceuticals SPRL
- Sasmar Cherry — Sasmar Pharmaceuticals SPRL
- Sasmar Classic — Sasmar Pharmaceuticals SPRL
- Sasmar Classic — Sasmar Pharmaceuticals SPRL
- Sasmar Melon — Sasmar Pharmaceuticals SPRL
- Sasmar Melon — Sasmar Pharmaceuticals SPRL
- Sasmar Original — Sasmar Pharmaceuticals SPRL
- Sasmar Pina Colada — Sasmar Pharmaceuticals SPRL
- Sasmar Pina Colada — Sasmar Pharmaceuticals SPRL
- Sasmar Strawberry — Sasmar Pharmaceuticals SPRL
- Sasmar Strawberry — Sasmar Pharmaceuticals SPRL
- Sasmar Vanilla — Sasmar Pharmaceuticals SPRL
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 |
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Manufacturer
- Manufacturer
- Sasmar Pharmaceuticals SPRL
Sources (1)
- FDA UDI 08583dce-a022-4cfb-98c5-98d79271967a 36 fields · synced Jun 6, 2026