Catalog Number

-

Brand Name

Autolith Touch

Version/Model Number

M0054668L0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K130368

Product Code

FFK

Product Code Name

Lithotriptor, Electro-Hydraulic

Public Device Record Key

d1f474de-9e88-4cc1-9b6f-c6646ba16eeb

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-