Catalog Number

-

Brand Name

Electrohydraulic Lithotripsy Probe 3 FR (1.0 mm) X 120 cm

Version/Model Number

E-3F

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

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

K980492,K980492

Product Code

FFK

Product Code Name

Lithotriptor, electro-hydraulic

Public Device Record Key

8dad6ca7-3ef7-4ad2-a497-891d699fd193

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 05, 2016

Package DI Number

00821925002050

Quantity per Package

3

Contains DI Package

00821925041769

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-