Catalog Number

XF36150

Brand Name

X-Filter basket

Version/Model Number

ROXE363609ST

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

5acda16e-e106-4245-ac75-624a2385e8a8

Public Version Date

May 06, 2022

Public Version Number

1

DI Record Publish Date

April 28, 2022

Package DI Number

03700512978596

Quantity per Package

1

Contains DI Package

03700512968597

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box