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Sonotrode S-PI

FDA UDI

Class II (US FDA UDI)

by Surgical Fusion Technologies GmbH

Identity

Trade Name
Sonotrode S-PI FDA UDI
Generic Name
Ultrasonic surgical system generator FDA UDI
Device Name
Sonotrode for Ultrasonic Handpiece FDA UDI
Model / Reference
Sonotrode S-PI FDA UDI
Description
Sonotrode for Ultrasonic Handpiece FDA UDI

Identifiers

Catalog Number
S04-002 FDA UDI
Primary DI / UDI-DI
07649990202303 FDA UDI
510(k) Number
K240288 FDA UDI
FDA Product Code
MAI FDA UDI
GAT FDA UDI
HTY FDA UDI
HWC FDA UDI
NKB FDA UDI
GMDN Term
Ultrasonic surgical system generator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
878.5000 FDA UDI
888.3040 FDA UDI
888.3070 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Ultrasonic surgical system generator

Sonotrode S-PI by Surgical Fusion Technologies GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasonic surgical system generator.

Cleared under the same submission

K240288 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Surgical Fusion Technologies GmbH

Sources (1)

  • FDA UDI 44011839-d2cb-4106-bfb0-8b5c37f95ca9 36 fields · synced May 30, 2026