Catalog Number

SOT 7/22-S

Brand Name

All Soft Ureteral Stent - 7F, 22cm with Suture

Version/Model Number

7F, 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)

Yes

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

73d3aac5-4f61-4966-abbe-4f38e25d67b7

Public Version Date

September 29, 2020

Public Version Number

1

DI Record Publish Date

September 21, 2020

Package DI Number

10812261013210

Quantity per Package

10

Contains DI Package

00812261013213

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-