trophon AcuTrace Medical Instrument Tag

Basic Information

• Brand Name: trophon AcuTrace Medical Instrument Tag
• Primary DI: 09350855000214
• Version / Model: N05007
• Company Name: NANOSONICS LIMITED
• Labeler DUNS: 741021943
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-06-15
• Public Version: 1
• Public Version Date: 2018-07-16
• Public Version Status: New
• Public Device Record Key: 08bae26d-3546-4c9c-aba3-3bfbc8e5ec07

Device Description

RFID Medical Instrument tag

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: Yes
• 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
OUG	Medical Device Data System	General Hospital	880.6310	1

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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09350855000214	GS1
Unit of Use	09350855000283	GS1