Catalog Number

PSD-QE5N

Brand Name

QC MicroPSD

Version/Model Number

PSD-QE5N

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"

Yes

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

064b9fb8-cd3f-46bc-9da7-a53a30d13f4b

Public Version Date

July 27, 2018

Public Version Number

2

DI Record Publish Date

March 23, 2018

Package DI Number

10851546007155

Quantity per Package

4

Contains DI Package

00851546007158

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box