Catalog Number

-

Brand Name

EchoStim

Version/Model Number

ES-20150

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K063380,K063380

Product Code

BSP

Product Code Name

Needle, Conduction, Anesthetic (W/Wo Introducer)

Public Device Record Key

08b265e8-f346-4f43-b3a4-8360516cf505

Public Version Date

June 03, 2022

Public Version Number

4

DI Record Publish Date

May 23, 2019

Package DI Number

14526737171125

Quantity per Package

25

Contains DI Package

04526737171128

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-