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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 handpiece cooling sleeve FDA UDI
Device Name
SonaStar Front Housing for Short Straight Handpiece FDA UDI
Model / Reference
CFSM6-H185 FDA UDI
Description
SonaStar Front Housing for Short Straight Handpiece FDA UDI

Identifiers

Primary DI / UDI-DI
00841626100176 FDA UDI
510(k) Number
K062471 FDA UDI
FDA Product Code
GEI FDA UDI
LFL FDA UDI
GMDN Term
Ultrasonic surgical system handpiece cooling sleeve 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 handpiece cooling sleeve

SonaStar by Misonix, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasonic surgical system handpiece cooling sleeve.

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 e0090007-41d7-497b-8522-a775126ddb4f 34 fields · synced Jun 9, 2026