Catalog Number

ROSH4000ST228

Brand Name

Nitinol Stone Extractor, helical basket, 4 wires, 4 Fr

Version/Model Number

09-0022

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"

Yes

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

-

Product Code

FFL

Product Code Name

Dislodger, Stone, Basket, Ureteral, Metal

Public Device Record Key

40c8404e-ad64-4736-b76b-bfb6fb97a44c

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

January 30, 2018

Package DI Number

03700512986263

Quantity per Package

4

Contains DI Package

03700512966265

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box