Catalog Number

-

Brand Name

Elesta - Introducer

Version/Model Number

CH2111. 6EC

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"

Yes

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

GAA

Product Code Name

Needle, Aspiration And Injection, Disposable

Public Device Record Key

a39692ed-80fd-4617-b62d-71e4cdd00c18

Public Version Date

October 10, 2022

Public Version Number

4

DI Record Publish Date

April 23, 2019

Package DI Number

08052286590029

Quantity per Package

20

Contains DI Package

08052286590005

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton Box