Handpiece SupraFuser

FDA UDI

Class II (US FDA UDI)

by Surgical Fusion Technologies GmbH

Identity

Trade Name: Handpiece SupraFuser FDA UDI
Generic Name: Ultrasonic surgical system generator FDA UDI
Device Name: Ultrasonic Handpiece FDA UDI
Model / Reference: Handpiece FDA UDI
Description: Ultrasonic Handpiece FDA UDI

Identifiers

Catalog Number: H04-003 FDA UDI
Primary DI / UDI-DI: 07649990202082 FDA UDI
510(k) Number: K171228 FDA UDI
K240288 FDA UDI
FDA Product Code: HWC FDA UDI
NKB FDA UDI
GAT FDA UDI
HTY FDA UDI
MAI FDA UDI
GMDN Term: Ultrasonic surgical system generator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
888.3070 FDA UDI
878.5000 FDA UDI
888.3030 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Ultrasonic surgical system generator

Handpiece SupraFuser by Surgical Fusion Technologies GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K171228 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: Surgical Fusion Technologies GmbH

Sources (1)

FDA UDI e8d3478d-02f7-40f9-9112-3b7067e4f090 36 fields · synced Jun 8, 2026