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rf-IVD 2

FDA UDI

Class II (US FDA UDI)

by Sun Nuclear Corp.

Identity

Trade Name
rf-IVD 2 FDA UDI
Generic Name
Solid-state-semiconductor radiation measuring probe FDA UDI
Device Name
Radiation therapy QA device. FDA UDI
Model / Reference
1136000-0Z FDA UDI
Description
Radiation therapy QA device. FDA UDI

Identifiers

Catalog Number
1136000-0Z FDA UDI
Primary DI / UDI-DI
05060608880041 FDA UDI
510(k) Number
K011332 FDA UDI
FDA Product Code
IYE FDA UDI
GMDN Term
Solid-state-semiconductor radiation measuring probe 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

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Solid-state-semiconductor radiation measuring probe

rf-IVD 2 by Sun Nuclear Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Solid-state-semiconductor radiation measuring probe.

Cleared under the same submission

K011332 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sun Nuclear Corp.

Sources (1)

  • FDA UDI aae96211-b145-4b98-90e7-a8de9f2719cb 36 fields · synced Jun 8, 2026