Catalog Number

-

Brand Name

ELIAN

Version/Model Number

ELIAN

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

K150506

Product Code

KPR

Product Code Name

System, X-Ray, Stationary

Public Device Record Key

f19184b3-ca12-46f6-a38b-2a0228caac72

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 16, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-