Catalog Number

-

Brand Name

Phosphor Storage Plate IDX S2

Version/Model Number

G3612

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

IWZ

Product Code Name

Film, Radiographic

Public Device Record Key

b26542c0-5ee0-46c7-932a-64116b88a933

Public Version Date

September 27, 2021

Public Version Number

1

DI Record Publish Date

September 19, 2021

Package DI Number

E247G36221

Quantity per Package

4

Contains DI Package

E247G36120

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-