Catalog Number

ROSH4000ST

Brand Name

ROCASTONE Extractor - Nitinol Helical Wire 4Fr - Basket: 16mm

Version/Model Number

ROSH4000ST

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

50b7f08e-1a82-4988-9aae-1c9cdcccb8b4

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

October 03, 2016

Package DI Number

03700512982746

Quantity per Package

4

Contains DI Package

03700512972747

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box label 2