HighSurg 11

FDA UDI

Class II (US FDA UDI)

by Nouvag AG

Identity

Trade Name: HighSurg 11 FDA UDI
Generic Name: Line-powered surgical power tool system motor FDA UDI
Device Name: Surgical motor system FDA UDI
Model / Reference: 3361 FDA UDI
Description: Surgical motor system FDA UDI

Identifiers

Primary DI / UDI-DI: ENOU33610 FDA UDI
510(k) Number: K042434 FDA UDI
FDA Product Code: HBC FDA UDI
ERL FDA UDI
GMDN Term: Line-powered surgical power tool system motor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4360 FDA UDI
874.4250 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

Yes

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: Line-powered surgical power tool system motor

HighSurg 11 by Nouvag AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Line-powered surgical power tool system motor.

DYONICS POWER — Smith & Nephew, Inc. · Class I
D'Liv Tip — Jeisys Medical Inc. · Class I
D'Liv Tip — Jeisys Medical Inc. · Class I
D'Liv Handpiece — Jeisys Medical Incorporated · Class I
DYONICS — Smith & Nephew, Inc. · Class I
D'Liv Tip — Jeisys Medical Inc. · Class I
D'Liv Tip — Jeisys Medical Incorporated · Class I
D'Liv Main Body — Jeisys Medical Inc. · Class I

Cleared under the same submission

K042434 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: Nouvag AG

Sources (1)

FDA UDI 82ee0bcd-b4a9-4136-8a7d-d00ef7dd1217 35 fields · synced May 30, 2026