Identity
- Trade Name
- Oil for Embryo Culture FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- Sterile light mineral oil. 500mL bottle. FDA UDI
- Model / Reference
- 9305-500ML FDA UDI
- Description
- Sterile light mineral oil. 500mL bottle. FDA UDI
Identifiers
- Catalog Number
- 9305 FDA UDI
- Primary DI / UDI-DI
- 00810195240224 FDA UDI
- 510(k) Number
- K011938 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
- 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
Category: IVF medium
Oil for Embryo Culture by Irvine Scientific, Llc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K011938 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Irvine Scientific, Llc
Sources (2)
- FDA UDI d0ded8e6-bc62-4bde-ab00-584b613582f4 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 5, 2026