Catalog Number

SET1312012

Brand Name

RocaStone Nitinol Stone Extractor Tipless 1.3Fx120cm, 12mm basket

Version/Model Number

SET1312012

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

8844258e-0cbe-4857-b1fc-3c568ccd6759

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

September 15, 2016

Package DI Number

03700512985549

Quantity per Package

4

Contains DI Package

03700512975540

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box 2