OARtrac OT-PSS

GUDID 00851546007097

MOSFET radiation therapy dosimetry system

Primary Device ID	00851546007097
NIH Device Record Key	dd06a313-147c-497b-95c4-2778b99be0ec
Commercial Distribution Status	In Commercial Distribution
Brand Name	OARtrac
Version Model Number	OT-PSS
Catalog Number	OT-PSS
Company DUNS	005744772
Company Name	RADIADYNE, L.L.C.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00851546007097 [Primary]

NZT	Dosimeter, Ionizing Radiation, Implanted

Steralize Prior To Use	false
Device Is Sterile	false

00851546007097	OARtrac Proprietary System Software for CDU
00851546007080	OARtrac Clinical Detector Unit (CDU) with its Charged Coupled Device (CCD) camera and the system
20851546007077	OARtrac Plastic Scintillating Detector - Duplex Disposable Skin Sensor Cable
20851546007060	OARtrac Disposable Gas Release Short Profile Prostate Immobilization Treatment Balloon Device Ki
00851546007196	OARtrac Plus Clinical Detector Unit (CDU)

Mark Image Registration \| Serial	Company Trademark Application Date
OARTRAC 85058928 4703944 Live/Registered	ANGIODYNAMICS, INC. 2010-06-09