Catalog Number

-

Brand Name

RocaJJ Soft Stent - Ø 7 Fr - Length 30cm

Version/Model Number

ROJS9730ST

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

a007ef1f-8520-4f7f-a2c2-117ce8b16b1d

Public Version Date

June 08, 2018

Public Version Number

1

DI Record Publish Date

May 08, 2018

Package DI Number

03700512983538

Quantity per Package

6

Contains DI Package

03700512973539

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX