Identity
- Trade Name
- mocom FDA UDI
- Generic Name
- Steam sterilizer FDA UDI
- Device Name
- Table top steam sterilizer to be used in medical and dental practices, hospitals, clinics, nursing homes, laboratories and other facilities to sterilize re-usable surgical instruments (including dental handpieces) and medical materials, heat and moisture resistant and compatible with steam sterilization process. The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products. FDA UDI
- Model / Reference
- B Futura-28 FDA UDI
- Description
- Table top steam sterilizer to be used in medical and dental practices, hospitals, clinics, nursing homes, laboratories and other facilities to sterilize re-usable surgical instruments (including dental handpieces) and medical materials, heat and moisture resistant and compatible with steam sterilization process. The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products. FDA UDI
Identifiers
- Catalog Number
- M7A770010 FDA UDI
- Primary DI / UDI-DI
- 08033837931218 FDA UDI
- 510(k) Number
- K151597 FDA UDI
- FDA Product Code
- FLE FDA UDI
- GMDN Term
- Steam sterilizer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6880 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Steam sterilizer
mocom by Cefla Societa' Cooperativa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K151597 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 |
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Manufacturer
- Manufacturer
- Cefla Societa' Cooperativa
Sources (1)
- FDA UDI 4939ea9b-4817-45d1-9074-5df836ec05e6 37 fields · synced Jun 8, 2026