OARtrac

Basic Information

• Brand Name: OARtrac
• Primary DI: 00851546007066
• Version / Model: ORB-60F
• Catalog Number: ORB-60F
• Company Name: RADIADYNE, L.L.C.
• Labeler DUNS: 005744772
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 151ebc19-f0e3-487f-9966-d8f33783c2d7

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NZT	Dosimeter, Ionizing Radiation, Implanted	Radiology	892.5050	2
PCT	Prostate Immobilizer Rectal Balloon	Radiology	892.5720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35159	Linear accelerator system	An assembly of devices designed to produce high-energy electrons to yield high-energy x-rays used for therapeutic applications, primarily to treat cancer. It provides a uniform radiation field of uniform intensity and predictable energy level, in a beam with well defined dimensions. The principle of operation is linear acceleration of electrons by means of electromagnetic (EM) microwaves. The output is used as a treatment beam on the patient, either directly or after passing a suitable target. The system typically includes signal analysis and display devices, patient and device supports, and software.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20851546007060	GS1	Shipper Box	5	In Commercial Distribution
Package	10851546007063	GS1	Shelf Box	10	In Commercial Distribution
Primary	00851546007066	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K141154	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -30 – 50 Degrees Celsius