Catalog Number

JFCS160

Brand Name

JFil® Ureteral Suture Stent

Version/Model Number

ROJV5716ST

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

c89114b2-aab3-4f25-bb6a-2adc1a08fc92

Public Version Date

April 14, 2022

Public Version Number

1

DI Record Publish Date

April 06, 2022

Package DI Number

03700512978350

Quantity per Package

1

Contains DI Package

03700512968351

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box