Catalog Number

-

Brand Name

UreTron Rigid Sterile Probe 3.1 x 370mm

Version/Model Number

URT-PR-3.1-370S

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

K160198,K160198

Product Code

FFK

Product Code Name

Lithotriptor, Electro-Hydraulic

Public Device Record Key

b5f9a183-600a-4102-bfdb-65bc21c96a91

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2016

Package DI Number

10854732006031

Quantity per Package

10

Contains DI Package

00854732006034

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-