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Mectron

FDA UDI

Class II (US FDA UDI)

by Mectron Spa

Identity

Trade Name
MECTRON FDA UDI
Generic Name
Ultrasonic surgical system torque wrench, reusable FDA UDI
Device Name
K11 is a torque wrench used for tightening inserts to the Mectron ultrasonic handpieces. FDA UDI
Model / Reference
K11 FDA UDI
Description
K11 is a torque wrench used for tightening inserts to the Mectron ultrasonic handpieces. FDA UDI

Identifiers

Catalog Number
02900170-001 FDA UDI
Primary DI / UDI-DI
E322029001700010 FDA UDI
510(k) Number
K242432 FDA UDI
FDA Product Code
DZI FDA UDI
ELC FDA UDI
GMDN Term
Ultrasonic surgical system torque wrench, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4120 FDA UDI
872.4850 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Ultrasonic surgical system torque wrench, reusable

Mectron by Mectron Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasonic surgical system torque wrench, reusable.

Cleared under the same submission

K242432 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mectron Spa

Sources (1)

  • FDA UDI 1b2f6778-d003-474e-a351-6605372453f9 36 fields · synced May 30, 2026