Catalog Number

-

Brand Name

Paragon 2

Version/Model Number

RT312

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 03, 2017

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K162687

Product Code

IZL

Product Code Name

System, X-Ray, Mobile

Public Device Record Key

c3395e42-307f-4180-a3d2-0c93c9c8e8f8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 03, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-