SNC Phantom (FS-QA) - Radiation therapy, machine QA device - SUN NUCLEAR CORP.

Duns Number:122240021

Device Description: Radiation therapy, machine QA device

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More Product Details

Catalog Number

1252300

Brand Name

SNC Phantom (FS-QA)

Version/Model Number

1252300

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

IXG

Product Code Name

Phantom, Anthropomorphic, Radiographic

Device Record Status

Public Device Record Key

3af4eca7-fa0e-435e-8356-bd32155c0139

Public Version Date

July 30, 2020

Public Version Number

1

DI Record Publish Date

July 22, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SUN NUCLEAR CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 26
2 A medical device with a moderate to high risk that requires special controls. 112