Catalog Number

ROXE03812ST

Brand Name

XenX – Stone Management Device (12cm tip length Mid Distal Stone)

Version/Model Number

ROXE03812ST

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

K123438,K123438

Product Code

FFL

Product Code Name

Dislodger, Stone, Basket, Ureteral, Metal

Public Device Record Key

e812bfb8-953c-437b-ad8f-7843222a2600

Public Version Date

November 06, 2020

Public Version Number

5

DI Record Publish Date

October 11, 2016

Package DI Number

03700512975243

Quantity per Package

1

Contains DI Package

03700512965244

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box Label