Catalog Number

TSN189

Brand Name

Transseptal Needle

Version/Model Number

TSN189

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

K172950,K172950

Product Code

DRC

Product Code Name

Trocar

Public Device Record Key

86abc872-a6ea-439a-8056-a8796e46ffed

Public Version Date

August 20, 2020

Public Version Number

2

DI Record Publish Date

November 28, 2018

Package DI Number

30858769006242

Quantity per Package

5

Contains DI Package

00858769006241

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box