Catalog Number

-

Brand Name

Econolith EM1000

Version/Model Number

SW-8-A999d

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K063504

Product Code

LNS

Product Code Name

Lithotriptor, Extracorporeal Shock-Wave,Urological

Public Device Record Key

1fc9e79e-a38b-4ca6-a9a0-dc80e3708f15

Public Version Date

September 10, 2018

Public Version Number

1

DI Record Publish Date

August 08, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-