Catalog Number

ROJS9828ST228

Brand Name

LumaFlex Double J stent, 2 open tips, Ch/Fr8/L.28cm, without wire

Version/Model Number

09-0139

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

FAD

Product Code Name

Stent, Ureteral

Public Device Record Key

47a069f6-ab9a-4fa9-b497-96903a27538c

Public Version Date

September 20, 2018

Public Version Number

1

DI Record Publish Date

August 20, 2018

Package DI Number

03700512987604

Quantity per Package

6

Contains DI Package

03700512977605

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box