Identity
- Trade Name
- ACTEON FDA UDI
- Generic Name
- Ultrasonic surgical system generator FDA UDI
- Device Name
- ultrasonic surgical system for cutting bone and bone substitutes Alternative DI : 10887587025735 FDA UDI
- Model / Reference
- 05.001.400 FDA UDI
- Description
- ultrasonic surgical system for cutting bone and bone substitutes Alternative DI : 10887587025735 FDA UDI
Identifiers
- Catalog Number
- F57710 FDA UDI
- Primary DI / UDI-DI
- 03609820577104 FDA UDI
- 510(k) Number
- K100410 FDA UDI
- FDA Product Code
- JDX FDA UDI
- GMDN Term
- Ultrasonic surgical system generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.4580 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ultrasonic surgical system generator
Acteon by Satelec — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Satelec
Sources (1)
- FDA UDI adf93797-9319-40b9-bb93-05c686c49c4c 37 fields · synced Jun 8, 2026