trophon Wireless Ultrasound Probe Holder

Basic Information

• Brand Name: trophon Wireless Ultrasound Probe Holder
• Primary DI: 09350855000573
• Version / Model: N05030-US
• Catalog Number: N05030-US
• Company Name: NANOSONICS LIMITED
• Labeler DUNS: 741021943
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2024-10-25
• Public Version: 1
• Public Version Date: 2024-11-04
• Public Version Status: New
• Public Device Record Key: 58669dec-429f-446c-ab89-aab64ecce578

Device Description

Contains the following devices: 1 trophon Wireless Ultrasound Probe Holder (UDI: 09350855000511) 1 trophon AcuTrace Medical Instrument Tag (UDI: 09350855000283)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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: Yes
• 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
11202	Device operating status label/tag, reusable	A label or a tag intended to indicate the operating/calibration status (e.g., calibrated, repair required, out of service) and/or sterility record of the device to which it is attached; it does not include any additional functionality and does not include a sterilization process indicator. It is typically constructed from a durable material and may be designed to a specific standard. This is a reusable device.	No	Active
13730	Device sterilization/disinfection container, reusable	A receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09350855000573	GS1
Unit of Use	09350855000511	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a clean and dry area away from potential contamination or damage.