Catalog Number

-

Brand Name

i-Dixel

Version/Model Number

i-Dixel

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K073704

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

f789f636-bbbc-4e22-afae-9836e1ae1ce8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-