Catalog Number

10140001Z

Brand Name

PC Electrometer (TNC)

Version/Model Number

1014400Z

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

8ed4dc29-1f34-4506-8f9a-f6af8a6c7b5f

Public Version Date

April 18, 2019

Public Version Number

1

DI Record Publish Date

April 10, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-