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Surgical handpiece 1:1

FDA UDI

Class II (US FDA UDI)

by Nouvag AG

Identity

Trade Name
Surgical handpiece 1:1 FDA UDI
Generic Name
Surgical power tool system handpiece, rotary, rechargeable battery-powered FDA UDI
Device Name
Surgical handpiece short FDA UDI
Model / Reference
1710nou FDA UDI
Description
Surgical handpiece short FDA UDI

Identifiers

Primary DI / UDI-DI
ENOU1710NOU0 FDA UDI
510(k) Number
K042434 FDA UDI
FDA Product Code
ERL FDA UDI
GMDN Term
Surgical power tool system handpiece, rotary, rechargeable battery-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.4250 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: Surgical power tool system handpiece, rotary, rechargeable battery-powered

Surgical handpiece 1:1 by Nouvag AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical power tool system handpiece, rotary, rechargeable battery-powered.

Cleared under the same submission

K042434 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nouvag AG

Sources (1)

  • FDA UDI 8bd9349f-c26f-4e68-a441-9b7be7e010d4 35 fields · synced Jun 8, 2026