Catalog Number

ROSS2500ST

Brand Name

Nitinol Stone Extractor, straight basket, 4 wires, 2.5 Fr

Version/Model Number

09-0019

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

317ff365-b006-4b5e-8b41-e43d17707538

Public Version Date

November 06, 2020

Public Version Number

4

DI Record Publish Date

November 09, 2017

Package DI Number

03700512986232

Quantity per Package

4

Contains DI Package

03700512976233

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box