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SNC125c (BNC)

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 1041

by Sun Nuclear Corp.

Identity

Trade Name
SNC125c EUDAMED
SNC125c (BNC) FDA UDI
SNC125c (TNC) FDA UDI
Generic Name
Solid-state-semiconductor radiation measuring probe FDA UDI
Device Name
SNC125c EUDAMED
Radiation therapy QA device. FDA UDI
Model / Reference
1041 EUDAMED
1041600Z FDA UDI
1041700Z FDA UDI
Description
Radiation therapy QA device. FDA UDI

Identifiers

Catalog Number
1041000-0Z FDA UDI
1041000-1Z FDA UDI
Primary DI / UDI-DI
05060608880225 EUDAMEDFDA UDI
05060608880119 FDA UDI
Basic UDI-DI
506060888DPSNC125cA7 EUDAMED
510(k) Number
K112981 FDA UDI
FDA Product Code
LHN FDA UDI
EMDN Code
Z11010180 LINEAR ACCELERATORS - HARDWARE ACCESSORIES EUDAMED
GMDN Term
Solid-state-semiconductor radiation measuring probe FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
892.5050 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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
MRI Safety
MR Conditional FDA UDI

Category: Solid-state-semiconductor radiation measuring probe

SNC125c (BNC) by Sun Nuclear Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K112981 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sun Nuclear Corp.

Sources (3)

  • FDA UDI 7ac1aa40-38d6-4839-870e-b2c567235bf5 36 fields · synced Jul 17, 2026
  • FDA UDI 395126c8-6b56-4cdf-9115-285c73991a84 36 fields · synced May 29, 2026
  • EUDAMED d5c1937a-2f53-4c4e-8ad8-0bf3df3f1b31 61 fields · synced Jul 17, 2026