Catalog Number

2012.901

Brand Name

NA

Version/Model Number

2012901

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FFK

Product Code Name

Lithotriptor, electro-hydraulic

Public Device Record Key

a96e7d90-f2aa-42e5-862d-5d1d6f0b2aa8

Public Version Date

January 08, 2021

Public Version Number

6

DI Record Publish Date

September 27, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-