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neXus

FDA UDI

Class U (US FDA UDI)

by Misonix, LLC

Identity

Trade Name
neXus FDA UDI
Generic Name
Soft-tissue ultrasonic surgical system handpiece tip, single-use FDA UDI
Device Name
neXus SonaStar® 1.9mm Notched, Standard Short Tip & Tubeset FDA UDI
Model / Reference
130-35-1499 FDA UDI
Description
neXus SonaStar® 1.9mm Notched, Standard Short Tip & Tubeset FDA UDI

Identifiers

Primary DI / UDI-DI
00841626103214 FDA UDI
510(k) Number
K190160 FDA UDI
FDA Product Code
LFL FDA UDI
GEI FDA UDI
GMDN Term
Soft-tissue ultrasonic surgical system handpiece tip, single-use FDA UDI

Classification

Device Class
U FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Soft-tissue ultrasonic surgical system handpiece tip, single-use

neXus by Misonix, LLC — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Soft-tissue ultrasonic surgical system handpiece tip, single-use.

Cleared under the same submission

K190160 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 7d48e3d5-4d3e-4c6e-8834-02cff6950403 34 fields · synced Jun 9, 2026