SonaStar

FDA UDI

Class II (US FDA UDI)

by Misonix, LLC

Identity

Trade Name: SonaStar FDA UDI
Generic Name: Surgical torque wrench, reusable FDA UDI
Device Name: SonaStar Autoclavable Torque Fixture FDA UDI
Model / Reference: CFSM6-T222 FDA UDI
Description: SonaStar Autoclavable Torque Fixture FDA UDI

Identifiers

Primary DI / UDI-DI: 00841626100114 FDA UDI
510(k) Number: K062471 FDA UDI
FDA Product Code: GEI FDA UDI
LFL FDA UDI
GMDN Term: Surgical 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

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

Yes

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: Surgical torque wrench, reusable

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

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Cleared under the same submission

K062471 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: Misonix, LLC

Sources (1)

FDA UDI 47f77041-7a29-4e87-a784-82759970ff96 34 fields · synced Jun 9, 2026