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SonaStar

FDA UDI

Class II (US FDA UDI)

by Misonix, LLC

Identity

Trade Name
SonaStar FDA UDI
Generic Name
Ultrasonic surgical system torque wrench, reusable FDA UDI
Device Name
SonaStar Autoclavable Torque Wrench FDA UDI
Model / Reference
CFSM2-T018 FDA UDI
Description
SonaStar Autoclavable Torque Wrench FDA UDI

Identifiers

Primary DI / UDI-DI
00841626100107 FDA UDI
510(k) Number
K062471 FDA UDI
FDA Product Code
GEI FDA UDI
LFL FDA UDI
GMDN Term
Ultrasonic surgical system torque wrench, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 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

Yes

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 torque wrench, reusable

SonaStar by Misonix, LLC — 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

K062471 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Misonix, LLC

Sources (1)

  • FDA UDI 0bc63e24-e933-4476-90b7-8ba9c7edff91 34 fields · synced Jun 9, 2026