Catalog Number

-

Brand Name

Elation™

Version/Model Number

00884450258033

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

Yes

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

FGE

Product Code Name

CATHETER, BILIARY, DIAGNOSTIC

Public Device Record Key

e6df9477-85d1-43cb-b0ea-82a72c99a944

Public Version Date

October 11, 2021

Public Version Number

4

DI Record Publish Date

March 03, 2016

Package DI Number

20884450258037

Quantity per Package

5

Contains DI Package

10884450258030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-