Catalog Number

M006840201R0

Brand Name

LITHOCLAST

Version/Model Number

FT-235R

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)

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

8ecdb7dc-59af-4ca9-a5a4-2695406e5ec8

Public Version Date

November 06, 2018

Public Version Number

3

DI Record Publish Date

August 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-