neXus

Basic Information

• Brand Name: neXus
• Primary DI: 00841626103580
• Version / Model: 120-31-13C3
• Company Name: MISONIX, INC.
• Labeler DUNS: 065963449
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-01
• Public Version: 1
• Public Version Date: 2020-07-09
• Public Version Status: New
• Public Device Record Key: e0a3170b-2658-4758-9fc9-944d093ecb96

Device Description

neXus Sonicone Curette Tip Excel Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LFL	Instrument, Ultrasonic Surgical	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
62141	Wound therapy ultrasound system handpiece tip	A sterile component of a wound therapy ultrasound (US) system intended to be attached to the system handpiece to interface low frequency US energy from the handpiece with a fluid solution (e.g., saline) for the production of an ultrasound-conductive mist used to promote wound healing. It typically includes fluid delivery tubing and is intended to fit on the distal end of the handpiece. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841626103580	GS1
Package	00841626103597	GS1	box	5	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K190160	000