Catalog Number

-

Brand Name

Lithotripsy Probe 1.9FR 375cm French

Version/Model Number

9-195-371-F

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

K914514

Product Code

FFK

Product Code Name

Lithotriptor, Electro-Hydraulic

Public Device Record Key

8ab4d4c2-58b4-47c5-ac85-f21ec4a2f4a0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 18, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-