Catalog Number

-

Brand Name

Lithotripsy Transducer ShockPulse-SE

Version/Model Number

SPL-T

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2019

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

-

Product Code

FEO

Product Code Name

Lithotriptor, Ultrasonic

Public Device Record Key

648a900b-ef92-4e62-b7fe-a296a68ad5dc

Public Version Date

November 30, 2021

Public Version Number

4

DI Record Publish Date

April 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-