Catalog Number

-

Brand Name

EM-19 LC

Version/Model Number

30281001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EBW

Product Code Name

Controller, Foot, Handpiece And Cord

Public Device Record Key

b8ec80a5-c9e2-4d44-b2dc-e5fa9217ed17

Public Version Date

October 30, 2018

Public Version Number

1

DI Record Publish Date

September 29, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-