Catalog Number

PATHVISION23X29

Brand Name

FAXITRON PATH

Version/Model Number

PATHVISION 23x29

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

K122428

Product Code

MWP

Product Code Name

Cabinet, x-ray system

Public Device Record Key

c4c1c4b7-13f8-4a0e-88c2-db1012ba8f86

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

August 17, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-