Catalog Number

-

Brand Name

Niti-S Biliary Slim M Stent

Version/Model Number

BN0812-6

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K221071

Product Code

FGE

Product Code Name

Stents, Drains And Dilators For The Biliary Ducts

Public Device Record Key

34bb084c-f160-4fcc-aa57-d7c112760e72

Public Version Date

June 30, 2022

Public Version Number

1

DI Record Publish Date

June 22, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-