Identity
- Trade Name
- ACTEON FDA UDI
- Generic Name
- Hard/soft-tissue ultrasonic surgical system FDA UDI
- Device Name
- Bone saw with four teeth, used for cutting the ramus cortical bone. Right oriented, it is used to create vertical and horizontal osteotomy lines on the patient’s left mandible. Alternative DI : 10887587009711 FDA UDI
- Model / Reference
- 03.000.404S FDA UDI
- Description
- Bone saw with four teeth, used for cutting the ramus cortical bone. Right oriented, it is used to create vertical and horizontal osteotomy lines on the patient’s left mandible. Alternative DI : 10887587009711 FDA UDI
Identifiers
- Catalog Number
- F87703 FDA UDI
- Primary DI / UDI-DI
- 03609820877037 FDA UDI
- 510(k) Number
- K100410 FDA UDI
- FDA Product Code
- JDX FDA UDI
- GMDN Term
- Hard/soft-tissue ultrasonic surgical system 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Category: Hard/soft-tissue ultrasonic surgical system
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 a2c0b252-e339-4e53-88f3-76cbc22f8fa8 36 fields · synced Jun 8, 2026