Identity
- Trade Name
- OARtrac FDA UDI
- Generic Name
- MOSFET radiation therapy dosimetry system FDA UDI
- Device Name
- OARtrac Plus Clinical Detector Unit (CDU) FDA UDI
- Model / Reference
- OT-CDU2P FDA UDI
- Description
- OARtrac Plus Clinical Detector Unit (CDU) FDA UDI
Identifiers
- Catalog Number
- OT-CDU2P FDA UDI
- Primary DI / UDI-DI
- 00851546007196 FDA UDI
- 510(k) Number
- K182395 FDA UDI
- FDA Product Code
- NZT FDA UDI
- GMDN Term
- MOSFET radiation therapy dosimetry system 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: MOSFET radiation therapy dosimetry system
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.
- mobileMOSFET — Best Medical Canada , Ltd. · Class II
- LANDAUER — Landauer · Class II
- Portable — Best Medical Canada , Ltd. · Class II
- OARtrac — RADIADYNE, L.L.C. · Class II
- OARtrac — RADIADYNE, L.L.C. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Radiadyne, L.l.c.
Sources (1)
- FDA UDI b62a0783-df74-4e78-b259-34f2c20f4923 36 fields · synced Jun 8, 2026