Catalog Number

SIXW1700

Brand Name

Six Wire Basket

Version/Model Number

ROKS1700ST245

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

aaeb72a9-82f9-4632-99b0-3df10fe5db68

Public Version Date

March 04, 2021

Public Version Number

1

DI Record Publish Date

February 24, 2021

Package DI Number

03700512978206

Quantity per Package

1

Contains DI Package

03700512968207

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box1