OARtrac

Basic Information

• Brand Name: OARtrac
• Primary DI: 00851546007073
• Version / Model: OT1-PSD-2U
• Catalog Number: OT1-PSD-2U
• Company Name: RADIADYNE, L.L.C.
• Labeler DUNS: 005744772
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: b6235f4a-1522-4ffa-9c50-deb251ea747b

Device Description

OARtrac Plastic Scintillating Detector - Duplex Disposable Skin Sensor Cable

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NZT	Dosimeter, Ionizing Radiation, Implanted	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60322	MOSFET radiation therapy dosimetry system dosimeter	A non-sterile device using metal oxide semiconductor field-effect transistor (MOSFET) technology that is a component of a MOSFET radiation therapy dosimetry system intended to be used for on-the-spot patient or anthropomorphic radiation dose verification and monitoring during a radiation therapy and radiology procedure. It consists of a small MOSFET dosimeter (sensor) at its distal end with an electrically-conductive wire proximally that connects to a dosimeter reader for the recording of radiation dose readings. It is typically placed (taped) on the patient in the area of interest for radiation therapy or placed in a catheter for in vivo brachytherapy application. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20851546007077	GS1	Shipper Box	5	In Commercial Distribution
Package	10851546007070	GS1	Shelf Box	10	In Commercial Distribution
Primary	00851546007073	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K150719	000