Catalog Number

-

Brand Name

Lithotripsy Probe 9FR 54cm

Version/Model Number

9-900-54

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)

Yes

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

K914516,K914516

Product Code

FFK

Product Code Name

Lithotriptor, Electro-Hydraulic

Public Device Record Key

fc64fbcd-2ddb-4e0c-9901-43ba44b5ee12

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 13, 2016

Package DI Number

10817183020179

Quantity per Package

3

Contains DI Package

00817183020172

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-