OARtrac

FDA UDI

Class II (US FDA UDI)

by Radiadyne, L.l.c.

Identity

Trade Name: OARtrac FDA UDI
Generic Name: Linear accelerator system FDA UDI
Device Name: OARtrac Disposable Gas Release Short Profile Prostate Immobilization Treatment Balloon Device Kit, with Fiducial Marker and PSD Sensor Bundle FDA UDI
Model / Reference: ORB-60F FDA UDI
Description: OARtrac Disposable Gas Release Short Profile Prostate Immobilization Treatment Balloon Device Kit, with Fiducial Marker and PSD Sensor Bundle FDA UDI

Identifiers

Catalog Number: ORB-60F FDA UDI
Primary DI / UDI-DI: 00851546007066 FDA UDI
510(k) Number: K141154 FDA UDI
FDA Product Code: NZT FDA UDI
PCT FDA UDI
GMDN Term: Linear accelerator system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.5050 FDA UDI
892.5720 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Linear accelerator system

OARtrac by Radiadyne, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K141154 also covers:

OARtrac — RADIADYNE, L.L.C.
OARtrac — RADIADYNE, L.L.C.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Radiadyne, L.l.c.

Sources (1)

FDA UDI 151ebc19-f0e3-487f-9966-d8f33783c2d7 37 fields · synced May 30, 2026