Catalog Number

-

Brand Name

Roentgen Files

Version/Model Number

4.1.0

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LMB

Product Code Name

Device, Digital Image Storage, Radiological

Public Device Record Key

42d7e8f2-8a9f-4a5b-928e-1b786b7e1d27

Public Version Date

June 11, 2021

Public Version Number

2

DI Record Publish Date

September 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-