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Acteon

FDA UDI

Class II (US FDA UDI)

by Satelec

Identity

Trade Name
ACTEON FDA UDI
Generic Name
Hard/soft-tissue ultrasonic surgical system FDA UDI
Device Name
General surgery ultrasonic handpiece Alternative DI : 10887587025766 FDA UDI
Model / Reference
05.001.401 FDA UDI
Description
General surgery ultrasonic handpiece Alternative DI : 10887587025766 FDA UDI

Identifiers

Catalog Number
F12818 FDA UDI
Primary DI / UDI-DI
03609820128184 FDA UDI
510(k) Number
K091331 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

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Hard/soft-tissue ultrasonic surgical system

Acteon by Satelec — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hard/soft-tissue ultrasonic surgical system.

Cleared under the same submission

K091331 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Satelec

Sources (1)

  • FDA UDI 5ee28f98-868c-4934-8c4f-7c2390638198 37 fields · synced Jun 8, 2026