Catalog Number

-

Brand Name

EchoStim EB

Version/Model Number

EB-21100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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,K063380

Product Code

BSP

Product Code Name

Needle, Conduction, Anesthetic (W/Wo Introducer)

Public Device Record Key

79a7cb6a-0f35-4223-95ed-5f4177fd691f

Public Version Date

October 10, 2022

Public Version Number

1

DI Record Publish Date

October 01, 2022

Package DI Number

14526737171156

Quantity per Package

25

Contains DI Package

04526737171159

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-