Catalog Number

M0068402870

Brand Name

LITHOCLAST

Version/Model Number

FR-290

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

K173234,K181364,K181997,K182490

Product Code

FEO

Product Code Name

Lithotriptor, Ultrasonic

Public Device Record Key

95d7a865-7dd0-49c9-96bf-5103b06a1a72

Public Version Date

January 08, 2021

Public Version Number

4

DI Record Publish Date

August 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-