PC Electrometer Reference Class Dual-Channel Electrometer (BNC) - Radiation therapy QA device. - SUN NUCLEAR CORP.

Duns Number:122240021

Device Description: Radiation therapy QA device.

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More Product Details

Catalog Number

1014000-0Z

Brand Name

PC Electrometer Reference Class Dual-Channel Electrometer (BNC)

Version/Model Number

1014300Z

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

K092019

Product Code Details

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Device Record Status

Public Device Record Key

d996ca38-82eb-4e42-9233-03ee9669aec9

Public Version Date

April 05, 2019

Public Version Number

2

DI Record Publish Date

March 05, 2019

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