Catalog Number

SOT 6/22-S

Brand Name

All Soft Ureteral Stent - 6F, 22cm with Suture

Version/Model Number

Ureteral Stent - 6F, 22cm with Suture

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"

-

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

K190659,K190659

Product Code

FAD

Product Code Name

Stent, Ureteral

Public Device Record Key

31de9868-6a7d-475d-8fd7-ea6432819eb1

Public Version Date

September 29, 2020

Public Version Number

1

DI Record Publish Date

September 21, 2020

Package DI Number

10812261010004

Quantity per Package

10

Contains DI Package

00812261010007

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-