OARtrac OT-CDU

GUDID 00851546007080

OARtrac Clinical Detector Unit (CDU) with its Charged Coupled Device (CCD) camera and the system’s own proprietary dose management software.

RADIADYNE, L.L.C.

MOSFET radiation therapy dosimetry system

• Primary Device ID: 00851546007080
• NIH Device Record Key: 3a184f6f-9ff8-4456-a0b4-8cbbd3c07a21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OARtrac
• Version Model Number: OT-CDU
• Catalog Number: OT-CDU
• 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

Customer Support Contacts

• Phone: 281-759-9600
• Email: leahroe@radiadyne.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851546007080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141154

FDA Product Code

• NZT: Dosimeter, Ionizing Radiation, Implanted

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [OARtrac]

• 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)