Catalog Number

ISN1915

Brand Name

Introducer Sheath/Needle

Version/Model Number

ISN1915

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

-

Product Code

FGE

Product Code Name

Stents, Drains And Dilators For The Biliary Ducts

Public Device Record Key

ad4550e6-c26d-49ef-b90b-b309666298ab

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

July 19, 2018

Package DI Number

20886333224382

Quantity per Package

10

Contains DI Package

00886333224388

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box