OARtrac OT1-PSD-2U

GUDID 20851546007077

MOSFET radiation therapy dosimetry system dosimeter

Primary Device ID	20851546007077
NIH Device Record Key	b6235f4a-1522-4ffa-9c50-deb251ea747b
Commercial Distribution Status	In Commercial Distribution
Brand Name	OARtrac
Version Model Number	OT1-PSD-2U
Catalog Number	OT1-PSD-2U
Company DUNS	005744772
Company Name	RADIADYNE, L.L.C.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00851546007073 [Primary]
GS1	10851546007070 [Package] Contains: 00851546007073 Package: Shelf Box [10 Units] In Commercial Distribution
GS1	20851546007077 [Package] Contains: 10851546007070 Package: Shipper Box [5 Units] In Commercial Distribution

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