Catalog Number

PSD-EE5N

Brand Name

Electron microPSD

Version/Model Number

PSD-EE5N

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

NZT

Product Code Name

Dosimeter, Ionizing Radiation, Implanted

Public Device Record Key

46e05118-be30-46cb-b482-accde1ec5391

Public Version Date

May 30, 2019

Public Version Number

1

DI Record Publish Date

May 22, 2019

Package DI Number

20851546007619

Quantity per Package

32

Contains DI Package

10851546007612

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box