OARtrac ORB-60F

GUDID 20851546007060

OARtrac Disposable Gas Release Short Profile Prostate Immobilization Treatment Balloon Device Kit, with Fiducial Marker and PSD Sensor Bundle

RADIADYNE, L.L.C.

Linear accelerator system

• Primary Device ID: 20851546007060
• NIH Device Record Key: 151ebc19-f0e3-487f-9966-d8f33783c2d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OARtrac
• Version Model Number: ORB-60F
• Catalog Number: ORB-60F
• 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: true
• 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

Customer Support Contacts

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

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851546007066 [Primary]
GS1	10851546007063 [Package]; Contains: 00851546007066; Package: Shelf Box [10 Units]; In Commercial Distribution
GS1	20851546007060 [Package]; Contains: 10851546007063; Package: Shipper Box [5 Units]; In Commercial Distribution

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: 2016-09-22

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)