Identity
- Trade Name
- FertiCult Mineral Oil FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- FertiCult™ Mineral Oil - MINOIL020 (20ml) FertiCult™ Mineral Oil is pre-washed, pharmaceutical grade, light parrafin oil. For the latest version of the instructions for use and MSDS, visit our product page on the FertiPro website (www.fertipro.com) FDA UDI
- Model / Reference
- MINOIL020 FDA UDI
- Description
- FertiCult™ Mineral Oil - MINOIL020 (20ml) FertiCult™ Mineral Oil is pre-washed, pharmaceutical grade, light parrafin oil. For the latest version of the instructions for use and MSDS, visit our product page on the FertiPro website (www.fertipro.com) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05411967000852 FDA UDI
- 510(k) Number
- K053494 FDA UDI
- FDA Product Code
- MQL FDA UDI
- GMDN Term
- IVF medium FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6180 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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
Dimensions & Sizes
- Size
- Total Volume — 20 Milliliter FDA UDI
FertiCult Mineral Oil by Fertipro NV — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K053494 also covers:
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- GM501 Gradient 100% — HAMILTON THORNE, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fertipro NV
Sources (2)
- FDA UDI e165d2ca-b81c-40fa-892c-93e3621a8f8f 38 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 1, 2026