Catalog Number

PSD-PE5N

Brand Name

Photon microPSD

Version/Model Number

PSD-PE5N

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 08, 2018

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

d486331c-18b7-48c7-97e4-44079d285371

Public Version Date

July 27, 2018

Public Version Number

2

DI Record Publish Date

May 08, 2018

Package DI Number

20851546007435

Quantity per Package

32

Contains DI Package

10851546007421

Package Discontinue Date

May 08, 2018

Package Status

Not in Commercial Distribution

Package Type

Shipper Box