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OARtrac

FDA UDI

Class II (US FDA UDI)

by Radiadyne, L.l.c.

Identity

Trade Name
OARtrac FDA UDI
Generic Name
MOSFET radiation therapy dosimetry system dosimeter FDA UDI
Device Name
OARtrac Plastic Scintillating Detector - Duplex Disposable Skin Sensor Cable FDA UDI
Model / Reference
OT1-PSD-2U FDA UDI
Description
OARtrac Plastic Scintillating Detector - Duplex Disposable Skin Sensor Cable FDA UDI

Identifiers

Catalog Number
OT1-PSD-2U FDA UDI
Primary DI / UDI-DI
00851546007073 FDA UDI
510(k) Number
K150719 FDA UDI
FDA Product Code
NZT FDA UDI
GMDN Term
MOSFET radiation therapy dosimetry system dosimeter FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: MOSFET radiation therapy dosimetry system dosimeter

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

Similar devices

Also classified as MOSFET radiation therapy dosimetry system dosimeter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Radiadyne, L.l.c.

Sources (1)

  • FDA UDI b6235f4a-1522-4ffa-9c50-deb251ea747b 36 fields · synced May 30, 2026