OARtrac OT-CDU2P

GUDID 00851546007196

OARtrac Plus Clinical Detector Unit (CDU)

RADIADYNE, L.L.C.

MOSFET radiation therapy dosimetry system

• Primary Device ID: 00851546007196
• NIH Device Record Key: b62a0783-df74-4e78-b259-34f2c20f4923
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OARtrac
• Version Model Number: OT-CDU2P
• Catalog Number: OT-CDU2P
• 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: true
• 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: sabrinamartilla@radiadyne.com
• Phone: 281-759-9600
• Email: sabrinamartilla@radiadyne.com
• Phone: 281-759-9600
• Email: sabrinamartilla@radiadyne.com
• Phone: 281-759-9600
• Email: sabrinamartilla@radiadyne.com
• Phone: 281-759-9600
• Email: sabrinamartilla@radiadyne.com
• Phone: 281-759-9600
• Email: sabrinamartilla@radiadyne.com
• Phone: 281-759-9600
• Email: sabrinamartilla@radiadyne.com
• Phone: 281-759-9600
• Email: sabrinamartilla@radiadyne.com
• Phone: 281-759-9600
• Email: sabrinamartilla@radiadyne.com
• Phone: 281-759-9600
• Email: sabrinamartilla@radiadyne.com
• Phone: 281-759-9600
• Email: sabrinamartilla@radiadyne.com
• Phone: 281-759-9600
• Email: sabrinamartilla@radiadyne.com
• Phone: 281-759-9600
• Email: sabrinamartilla@radiadyne.com
• Phone: 281-759-9600
• Email: sabrinamartilla@radiadyne.com
• Phone: 281-759-9600
• Email: sabrinamartilla@radiadyne.com
• Phone: 281-759-9600
• Email: sabrinamartilla@radiadyne.com
• Phone: 281-759-9600
• Email: sabrinamartilla@radiadyne.com
• Phone: 281-759-9600
• Email: sabrinamartilla@radiadyne.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851546007196 [Primary]
GS1	20851546007190 [Package]; Package: Case [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182395

FDA Product Code

• NZT: Dosimeter, Ionizing Radiation, Implanted

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-11
• Device Publish Date: 2019-07-03

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)