Catalog Number

-

Brand Name

LITHOCLAST

Version/Model Number

EL-420B

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

K012445

Product Code

FFK

Product Code Name

Lithotriptor, Electro-Hydraulic

Public Device Record Key

6f3df81c-3ef5-4c72-9c10-f8f84663f1ba

Public Version Date

October 15, 2019

Public Version Number

1

DI Record Publish Date

October 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-