trophon2 Refurbished

Basic Information

• Brand Name: trophon2 Refurbished
• Primary DI: 09350855001037
• Version / Model: N05000-1R
• Company Name: NANOSONICS LIMITED
• Labeler DUNS: 741021943
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-01
• Public Version: 1
• Public Version Date: 2025-11-10
• Public Version Status: New
• Public Device Record Key: 1aba2705-3fd1-49a3-9eee-56fc9c8ecd82

Device Description

This is a refurbished trophon2

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OUJ	High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66554	Multiple clinical chemistry analyte electrode IVD	An electrochemical sensor intended to be used to selectively measure electrical potential resulting from an enzymatic reaction, typically involving multiple immobilized enzymes, to determine the concentration of multiple clinical chemistry analytes (e.g., glucose, lactate) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09350855001037	GS1

Premarket Submissions

Submission Number	Supplement Number
K173865	000