Catalog Number

SET1912016

Brand Name

RocaStone Nitinol Stone Extractor Tipless 1.9Fc120cm 16mm basket

Version/Model Number

SET1912016

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

b6f6a3ff-771b-4c2d-a235-e74dfdee0d9f

Public Version Date

January 01, 2020

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

03700512985556

Quantity per Package

4

Contains DI Package

03700512975557

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box 2